Systems and devices for setting an anchor

ABSTRACT

An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

PRIORITY

This application claims the benefit of and priority to the U.S.Provisional application, entitled “Systems And Devices For Setting AnAnchor,” filed on Nov. 17, 2015 having application Ser. No. 62/256,527and U.S. Provisional application, entitled “Ultrasound Probe for CardiacTreatment,” filed on Nov. 17, 2015 having application Ser. No.62/256,524, which application is incorporated by reference herein in itsentirety.

BACKGROUND

Heart failure can occur when the left ventricle of the heart becomesenlarged and dilated as a result of one or more of various etiologies.Initial causes of heart failure can include chronic hypertension,myocardial infarction, mitral valve incompetency, and other dilatedcardiomyopathies. With each of these conditions, the heart is forced tooverexert itself in order to provide a cardiac output demanded by thebody during various demand states. The result can be an enlarged leftventricle.

A dilated or enlarged heart, and particularly a dilated or enlarged leftventricle, can significantly increase tension and stress in heart wallsboth during diastolic filling and systolic contraction, whichcontributes to further dilatation or enlargement of chambers of theheart. Prior treatments for heart failure include pharmacologicaltreatments, assist devices such as pumps, and surgical treatments suchas heart transplant, dynamic cardiomyoplasty, and Batista partial leftventriculectomy. These prior treatments are described briefly in U.S.Pat. No. 5,961,440, entitled “Heart Wall Tension Reduction Apparatus andMethod,” issued on Oct. 5, 1999, the entirety of which is incorporatedby reference herein.

A more recent concept for treating heart failure applies one or moresplints onto the heart, to reduce myocardial muscular stressesencountered during pumping. Examples of such approaches are disclosed inU.S. Pat. No. 7,766,812, entitled “Methods and devices for improvingmitral valve function,” issued on Aug. 3, 2010, the entirety of which isincorporated herein by reference. One example includes one or moretransventricular splints placed across the left ventricle. Each splintmay include a tension member extending across the ventricle with anchorsdisposed on opposite ends of the tension member and placed on theexternal surface of the heart.

Mitral valve incompetency or mitral valve regurgitation is a commoncomorbidity of congestive heart failure. As the dilation of theventricle increases, valve function generally worsens, which results ina volume overload condition. The volume overload condition furtherincreases ventricular wall stress, thereby advancing the dilationprocess, which further worsens valve dysfunction.

In heart failure, the size of the valve annulus (particularly the mitralvalve annulus) increases while the area of the leaflets of the valveremains constant. This may lead to an area of less coaptation of thevalve leaflets, and, as a result, eventually to valve leakage orregurgitation. Moreover, in normal hearts, the annular size contractsduring systole, aiding in valve coaptation. In heart failure, there ispoor ventricular function and elevated wall stress. These conditionstend to reduce annular contraction and distort annular size, oftenexacerbating mitral valve regurgitation. In addition, as the chamberdilates, the papillary muscles (to which the leaflets are connected viathe chordae tendonae) may move radially outward and downward relative tothe valve, and relative to their normal positions. During this movementof the papillary muscles, however, the various chordae lengths remainsubstantially constant, which limits the full closure ability of theleaflets by exerting tension prematurely on the leaflets. This conditionis commonly referred to as “chordal tethering.” The combination ofannular changes and papillary changes results in a poorly functioningvalve.

It can be desirable to provide a therapy which corrects the valveincompetency. A heart with even a small amount of regurgitation maybenefit from not only the stress reducing functions of the ventricularsplints as described above, but also from an elimination of theregurgitation, which will further off-load pumping requirements of themyocardium.

Surface area of an anchor and/or size of the anchor can correspond tothe ability of an anchor to withstand forces due to tension fromreshaping the heart and ongoing beating of the heart (although, otherdesign features and material properties may also contribute to theability of the anchor to withstand tension forces). To be most effectiveand safe, anchors would ideally be able to withstand high forces,including forces as high as 17 Newtons (N) or higher, while the splintmaintains the heart in a desired shape. Further, the anchor should havea large enough surface area to spread out and reduce the pressure on themyocardium. If the pressure gets too high on an area (e.g., a small,focused pressure area) of the heart, this can lead to myocardiumnecrosis, which can itself lead to migration and sinking of the anchorinto the tissue. Accordingly, large anchors, or anchors with a largesurface area, may be required, and the larger size/area can makeimplantation of the anchor difficult and can require opening the heart,chest, and/or sternum, and/or may require other highly invasiveprocedures.

Currently available methods of mitral valve repair or replacementtypically require opening the chest and/or heart, e.g., to gain directaccess to the valve and its annulus or another portion of the heart.This type of access typically necessitates a use of cardiopulmonarybypass, which can introduce additional complications to the surgicalprocedure. Since the implantation of the splints themselves do notrequire the patient to be on cardiopulmonary bypass, it would beadvantageous to devise a technique which could improve the mitral valvewithout any need for cardiopulmonary bypass. The ability to improve themitral valve function without the need for cardiopulmonary bypass wouldbe an advantage, both in conjunction with ventricular splinting, andalso as a stand-alone therapy. Indeed, it would be desirable to havesystems, apparatuses, and methods capable of a deploying an anchor withan ability to withstand high pressures (e.g., an anchor having a largesurface area) using a less invasive, or minimally invasive procedure.

Devices and methods for medical treatment that may be used for improvingheart valve function are described herein. These may include aself-expandable anchor system and related methods for assisting intreating an apposition of heart valve leaflets so as to improve poorlyfunctioning heart valves, using less invasive treatments/procedures.

SUMMARY

Systems, assemblies, apparatuses, and related methods are provided formedical treatment, including for transcatheter medical treatments and/orfor treatment of dilated hearts (e.g., dilated left ventricle) orfunctional mitral valve regurgitation within a human heart. Anytreatment of a dilated left ventricle may simultaneously result intreatment (fixing or prevention) of functional mitral valveregurgitation. The systems, assemblies, apparatuses, and methods mayinclude an anchoring system that comprises an anchor for securing amitral valve splint (“MV Splint”) in the heart. A spade-shaped assembly(while the term “spade-shaped” is used, this is meant to encompasses avariety of different shapes and sizes) may be configured to be deployedin a right ventricle of the heart and to stabilize a catheter duringpenetrating the septum. An outer curved needle may be configured topenetrate the septum. The outer curved needle may comprise a hollow tubehaving a multiplicity of slits (e.g., S-shaped slits) disposed along thelength of the needle so as to accommodate sharp curving of the needle.The outer curved needle may be further configured to deploy an innerneedle into the left ventricle. A trocar catheter may be configured forpuncturing tissue within the heart without damaging other nearby tissue.An introducer system or introducer assembly for interventionalcardiology procedures may comprise an atraumatic and/or blunt shapeintroducer to protect nearby tissue within the heart during advancing aguidewire through a moving tissue, such as a beating heart. A threadedintroducer may be configured for advancing a guidewire and/or otherinstruments through a moving tissue, such as a beating heart, in acontrolled manner that helps prevent damage to surrounding tissue.

In an exemplary embodiment, an anchoring system for medical treatment,including treatment of heart dilation and/or functional mitral valveregurgitation comprises an anchor that can be used for fixating asplint, e.g., a mitral valve splint within a human heart. The anchoringsystem may include one or more or all of the following: a spade-shapedassembly configured to be deployed in a right ventricle of the heart andto stabilize a catheter during penetrating the septum between the rightventricle and the left ventricle; a curved needle configured topenetrate the septum, the curved needle comprising a hollow tube havinga multiplicity of slits (e.g., S-shaped slits) disposed along the lengthof the curved needle, the curved needle may be configured to passthrough a catheter or a portion of the spade-shaped assembly and mayalso be configured to deploy an inner needle from the curved needle intothe left ventricle; a trocar catheter configured for puncturing tissue;an introducer system for interventional cardiology procedures; and athreaded introducer configured for temporarily anchoring in a movingtissue and allowing advancement of a guidewire and/or other instrumentstherethrough.

In one exemplary embodiment, an anchor (e.g., of an anchoring system)comprises a ring having a circularly configured wire having atraumaticends which meet at a break, the wire capable of being expanded into astraightened configuration suitable for loading the anchor into a lumenof a catheter, e.g., a delivery catheter. In one embodiment the ring maybe formed of a shape memory material (e.g., nitinol or other shapememory alloy) and/or may have elastic properties. In one embodiment, thering may be formed from stainless steel or another strong material. Inone exemplary embodiment, the atraumatic ends of the wire forming thering comprise spherical portions of the wire configured to preventdamage to nearby tissues during delivery and deployment of the anchorwithin the heart. The anchor may also comprise a cover in one ormultiple pieces, the cover may be supported by the ring so as to assumea generally circular configuration. The cover may also be configured tocontact an exterior surface of the heart and/or allow tissue ingrowthinto the cover. A tension member (e.g., a cord, cable, wire, braidedfibers, etc.) may be engaged with the cover such that pulling thetension member or cord tightens the cover into a deployed configuration(e.g., a circular, disc-shaped, pie-shaped, or cone-shapedconfiguration). In one exemplary embodiment, the cover is configured tochange from the deployed configuration (e.g., circular, flattened,disc-shaped, pie-shaped, or cone-shaped configuration) to a collapsed orlow profile configuration when the cord is loosened. In one exemplaryembodiment, the cover may comprise a surface area suitable to eliminateor limit migration of the anchor into tissue of the heart and towithstand forces due to tension of the tension member or cord of 10-25Newtons (N), 14-20 N, or at least 17 N.

In one exemplary embodiment, the anchor or a portion of the anchor(e.g., the ring and/or the cover) is configured to bestretched/opened/changed from an expanded or deployed configuration(e.g., a circular or ring-shaped configuration) to a low profileconfiguration (e.g., a straightened configuration) such that the anchormay be loaded into a lumen of a catheter for delivery through a puncturewithin the heart in the low profile configuration, and wherein theanchor changes from the low profile configuration (e.g., straightenedconfiguration) to the deployed configuration (e.g., the circular orring-shaped configuration) as it is pushed out of the lumen of thecatheter. When in the deployed configuration (e.g., acircular/ring-shaped/pie-shaped/cone-shaped configuration), pulling thetension member or cord draws the cover taut toward the center of thecircle/ring, thereby producing the an expanded configuration of thecover (e.g., a circular, flattened/disc-shaped/pie-shaped configurationof the cover) when not tensioned against the heart wall. The tensionmember or cord can pull the anchor against the exterior surface of theheart wall, myocardium, and/or pericardium such that the anchor laysflat against the surface with the tension member or cord passing throughthe puncture in the heart wall, myocardium, and/or pericardium; however,as the tension is increased the tension member or cord can pull thecenter of the anchor inwardly causing the anchor and its cover to takeon a cone-like shape.

In one exemplary embodiment, the cover of an anchor may be comprised ofa strip of suitable material having a first, straight edge folded overto form a hole or passage extending along the length of the strip andconfigured to receive the ring, and a second edge comprising a seriesfolded tabs configured to receive the tension member or cord wherebypulling the tension member or cord draws the cover into thecircular/disc-shaped/pie-shaped configuration. In one exemplaryembodiment, the cover is comprised of any of various polymer materials,such as polyethylene terephthalate (PET), ultra-high-molecular-weightpolyethylene (UHMWPE), or other similar material. In one exemplaryembodiment, the cover further comprises one or more ribbons of thepolymer material woven so as to provide an anchor suitable forcontacting an exterior surface of the heart. The cover may comprise orconsist of a polymer, PET, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (ePTFE), UHMWPE, a metal, and/or a non-metal(e.g., carbon fibers).

In one exemplary embodiment, an anchor (e.g., of an anchoring system)may comprise a coiled wire. The coiled wire may comprise a base portionand a top portion, the base portion may be configured to contact theexterior surface of the heart, the myocardium, and/or the pericardium,the top portion may be configured to fixedly receive the tension memberor a cord drawn through the center of the coiled wire and the puncturein the heart, and the coiled wire may comprise several turns in whichthe diameter of the coil decreases in passing from the base portion tothe top portion. In one exemplary embodiment, the diameter of eachadjacent turn of the several turns of the coiled wire may decrease witha difference less than the diameter of the wire so as to configure acone-shaped anchor possessing a large area of contact with the surfaceof the heart. In one exemplary embodiment, the diameter of adjacentturns/coils of the several turns/coils decreases with a differencegreater than the diameter of the wire so as to configure atelescope-shaped anchor which provides a large contact area thatincreases as a function of tension in the tension member or cord. In oneexemplary embodiment, the coiled wire may be wound so as to form atleast a lower level or base portion and an upper level or top portion,the lower level being configured to provide a relatively large area ofcontact with the exterior surface of the heart while preventing theupper level and the tension member or cord from being drawn undertension into the puncture in the wall of the heart. In one embodiment,multiple coils of the coiled wire may have the same or a similardiameter.

In one exemplary embodiment, a spade-shaped assembly (e.g., of ananchoring system) may comprise a catheter, a needle (e.g., a firstneedle), and a wire spade. The catheter may include a lumen, and thecatheter may be flexible. The needle may include a sharp distal end,which may be configured for puncturing a septum between the rightventricle and a left ventricle of a heart (e.g., a beating heart). Theneedle may be disposable within the lumen of the catheter and moveableout of the lumen to puncture tissue, e.g., to puncture the septum. Theneedle may be curved and/or flexible. The needle may freely pass throughthe lumen, may be connected through controls at a proximal end (e.g., ona proximal handle or orientation handle), and/or may be connected to thecatheter by way of a catheter head. The wire spade may be connected tothe catheter, may be configured to be deployed in a right ventricle ofthe heart, and may be configured to contact walls of the right ventricleand thereby stabilize the needle when the needle is used to penetratethe tissue/septum, e.g., stabilize the needle when the needle penetratesthe septum between the right ventricle and the left ventricle and entersinto the left ventricle. The wires spade may have a variety of shapesand branches. The wire spade may be connected to the catheter by way ofa catheter head. The spade-shaped assembly may also comprise an innerneedle (e.g., a second needle) disposed within an inner lumen of thefirst needle, the inner needle may be configured to be advanced out of alumen of the first needle, across the left ventricle, and configured topuncture a posterior wall of the left ventricle after the first needlehas passed through the septum. The spade-shaped assembly may alsocomprise an orientation handle located at a proximal end of the catheterconfigured to provide control of an angle between a tip of the needleand the catheter and/or the wire spade. In one exemplary embodiment, thefirst needle and/or second, inner needle may comprise a hollow tubehaving a multiplicity of slits (e.g., S-shaped slits, C-shaped slits,V-shaped slits, zig zag slits, straight slits, diagonal slits, parallelslits, and/or other types of slits) disposed along the full length or aportion of the length of the needle. The slits (e.g., S-shaped slits)may be configured to allow the first needle and/or second, inner needleto undergo sharp turns when delivered inside the catheter and thenresume a straightened orientation when extended out from the catheter.The slits (e.g., S-shaped slits) may be further configured to providerigidity to the first needle and/or second, inner needle. In oneexemplary embodiment, the slits (e.g., S-shaped slits) are configured toallow the orientation of the first needle and/or second, inner needle tobe changed by rotating a proximal end of the first needle and/or second,inner needle extending from the catheter.

In one exemplary embodiment, a trocar catheter (e.g., of an anchoringsystem) may comprise a cannula being generally elongate and having aninterior lumen. The trocar catheter may also include a trocar disposedwithin the interior lumen and extending to a trocar distal tipcomprising one or more surfaces configured to puncture the tissue (e.g.,puncture the tissue during rotation of the trocar). A central lumen maypass through the trocar catheter (e.g., through the cannula and/or thetrocar) and may be in fluid communication with one or more lateral portsdisposed on the trocar distal tip. The central lumen and the one or morelateral ports may be configured for contrast injection. The trocarcatheter may include a proximal handle comprising a plunger mechanismand an actuator configured to facilitate advancing the trocar distal tipbeyond a distal end of the cannula during puncturing of the tissue. Theplunger mechanism may be further configured to withdraw the trocardistal tip into the distal end of the cannula during uses other thanpuncturing the tissue.

In one exemplary embodiment, an introducer system/assembly comprises aneedle catheter having an inner lumen and a beveled edge configured forpuncturing tissue and comprises an introducer having a guidewire lumenand an atraumatic and/or blunt shape of its distal end. The introducermay be disposed within the inner lumen of the needle catheter with itsatraumatic/blunt shaped distal end extending distally beyond the bevelededge of the needle catheter. A spring may be disposed within thecatheter configured to maintain the atraumatic/blunt shape extendingdistally beyond the beveled edge during uses other than puncturingtissue. A guidewire may be inserted into or otherwise disposed withinthe guidewire lumen of the introducer, the guidewire may be deliverablewhile the introducer distal end is extended to protect nearby tissuesfrom damage from the beveled edge of the needle catheter. In oneexemplary embodiment, the introducer and the needle catheter areconfigured such that the atraumatic/blunt shaped distal end of theintroducer may be locked into the distally extended position so as toenable pushing against tissue without the beveled edge of the needlecatheter puncturing the tissue.

In one exemplary embodiment, a threaded introducer (e.g., of ananchoring system) comprises an elongate member having a proximal headand a distal end. Both the proximal head and the distal end may haveatraumatic surface features so as to prevent damage to tissues duringdelivery of the threaded introducer. A central lumen may extend throughthe length of the threaded introducer, e.g., from the proximal head tothe distal end. The central lumen in the region within the proximal headmay be configured to receive a catheter, and the central lumen in theregion within the distal end may be configured for injection of contrastfluid (e.g., for imaging procedures). At least one lateral port may bedisposed on the distal end and be in fluid communication with thecentral lumen. A multiplicity of threads may be disposed along thelength of the threaded introducer and configured to engage with tissueas the threaded introducer is threaded into the tissue so as tofacilitate controlled advancement within a moving tissue (e.g., movingheart tissue).

In one exemplary embodiment, a suture cutter catheter comprises: amoving plate; a blade; and an inflatable balloon, wherein the suturecutter catheter may be configured such that inflation of the ballooncauses the moving plate to move toward the blade. The suture cuttercatheter may also comprise a spring that biases the moving plate in adirection away from the blade. The suture cutter catheter may alsocomprise a plastic positioning tube having a lumen through which asuture may be received, the positioning tube attached to the movingplate such that the positioning tube is configured to maintain thesuture in a desired position for cutting the suture. Other featuresdescribed with respect to suture cutter catheters herein may also beincluded.

In one exemplary embodiment, a catheter/device (e.g., a C-shapedcatheter/device or puncture location catheter/device) for identifying apuncture site (e.g., on a wall of a heart) during medical treatment iscapable of causing a bend/bulge in a wall of a heart. Thecatheter/device may comprise: a proximal handle; a positioning tubecoupled with the proximal handle, the positioning tube may include anelongate portion and a curved portion, and these may be integral and/orconnected together in a variety of ways, e.g., a proximal bend may bepositioned between them or connect them. The curved portion may have aradius of curvature configured for extending around a portion of anorgan or heart (e.g., around the left side of a heart. An elbow may bedisposed at a distal end of the curved portion. The catheter/device mayinclude a guide aligned with a longitudinal axis of the elongateportion, and may include a finger moveable relative to the guide. Theelbow may be configured/designed such that the guide and/or finger areoriented and aligned with a longitudinal axis of the elongate portion.The device/catheter may also include an applicator disposed near theproximal handle, the applicator being connected to the finger via aconnector that passes within a first lumen of the curved portion, suchthat the applicator can be manipulated to move the finger relative tothe guide.

In one exemplary embodiment, alignment of the finger with thelongitudinal axis of the elongate portion may be configured to helpindicate a location and orientation of the finger near the posteriorwall of the human heart. In one exemplary embodiment, a spring isconfigured to bias the finger in a retracted configuration such that apressing force applied to the applicator compresses the spring andtransitions the finger to an extended configuration, and wherein uponremoval of the pressing force the spring automatically transitions thefinger back to the retracted configuration. The positioning tube maycomprise one or multiple lumens. A second lumen, different from thefirst lumen, may be configured for deploying an anchor at the puncturesite during medical treatment. The catheter/device may be a C-shapeddevice/catheter or puncture location device/catheter as describedelsewhere herein and may include any of the described features and beused in any of the described methods or steps.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings refer to embodiments of the present disclosure in which:

FIG. 1A is a vertical cross-sectional view of left and right ventriclesof a human heart illustrating an orientation of an exemplary mitralvalve splint; an optional (or alternative) mitral valve splint with oneanchor against the septum of the heart is also shown in outline;

FIG. 1B is a transverse cross-sectional view of the left and rightventricles illustrating an orientation of an exemplary mitral valvesplint used in combination with a transventricular splint for lesseningmyocardial muscular stresses and assisting in apposition of valveleaflets.

FIG. 2A is a vertical cross-sectional view of left and right ventriclesof a human heart illustrating another possible orientation of anexemplary mitral valve splint;

FIG. 2B is a transverse cross-sectional view of the left and rightventricles illustrating an orientation of an exemplary mitral valvesplint, which may be the same as or similar to that shown in FIG. 2A;

FIG. 3A illustrates an exemplary embodiment of a self-expandable anchorsuitable for anchoring a mitral valve splint, the anchor having a ringin a circular configuration and a cover in a disc-shaped configuration;

FIG. 3B illustrates the self-expandable anchor of FIG. 3A transitioningbetween a straightened, low-profile configuration inside a catheter anda deployed configuration;

FIG. 4A is a perspective view illustrating an exemplary embodiment of aring which may be incorporated into a self-expandable anchor;

FIG. 4B is a top view illustrating the exemplary embodiment of the ringillustrated in FIG. 4A;

FIG. 4C is a side view illustrating the exemplary embodiment of the ringillustrated in FIG. 4A;

FIG. 4D is an isometric view illustrating an exemplary embodiment of anotched tube in a circular configuration that may be used as part of anexpandable anchor;

FIG. 4E is a perspective view illustrating the notched tube of FIG. 4Din a straightened, low profile configuration suitable for positioninginside a catheter;

FIG. 5A is a top view illustrating an exemplary embodiment of a cover inan open, unfolded configuration which may be incorporated into aself-expandable anchor;

FIG. 5B is a top view illustrating the exemplary embodiment of the coverillustrated in FIG. 5A in a folded configuration;

FIG. 5C is a side view illustrating the exemplary embodiment of thecover of FIG. 5A in the folded configuration;

FIG. 6A illustrates an exemplary embodiment of an anchor comprising aring attached to a tension member by way of a multiplicity of spokes;

FIG. 6B illustrates an exemplary embodiment of an anchor comprising acircular cover mounted onto a ring;

FIG. 6C illustrates an exemplary embodiment of an anchor comprising acircular ring attached to a tension member by way of several spokes, aninner ring, and one or more polymer ribbons;

FIG. 7A is a perspective view illustrating an exemplary embodiment of ananchor comprising an expandable balloon attached to a tension member;

FIG. 7B is a perspective view illustrating an exemplary embodiment of ananchor comprising an expandable balloon coupled with a filling tube anda spring locker;

FIG. 7C is a cross-sectional view of an anchor comprising an expandableballoon that may be similar to the anchor of FIG. 7B that shows fluidcommunication between a filling tube and an interior of the expandableballoon;

FIG. 7D is a cross-sectional view illustrating an exemplary embodimentof an anchor comprising an expandable balloon with a filled interior;

FIG. 8A is a side cross-sectional view of an exemplary embodiment of aself-expandable anchor comprising a balloon and an internal wire ringthat are in a low profile configuration suitable for being deployedinside a catheter;

FIG. 8B is perspective view of an expanded configuration of theself-expandable anchor illustrated in FIG. 8A;

FIG. 9A is a perspective view illustrating an exemplary embodiment of ananchor;

FIG. 9B is a cross-sectional view taken along a midline of the anchorillustrated in FIG. 9A;

FIG. 10A is a perspective view illustrating an exemplary embodiment ofanother anchor;

FIG. 10B is a cross-sectional view taken along a midline of the anchorof FIG. 10A;

FIG. 11A is a perspective view illustrating an exemplary embodiment ofanother anchor;

FIG. 11B is a cross-sectional view taken along a midline of the anchorillustrated in FIG. 11A;

FIG. 12A is a side view illustrating an exemplary embodiment of aspade-shaped assembly for use with a transcatheter system;

FIG. 12B is a top view of the exemplary embodiment of the spade-shapedassembly illustrated in FIG. 12A;

FIG. 12C illustrates another exemplary embodiment of a spade-shapedassembly configured for use with a transcatheter system;

FIG. 13 illustrates an exemplary embodiment of a spade-shaped assemblycomprising a curved needle a distal end of which is angled atsubstantially 90 degrees relative to a catheter;

FIG. 14A is a side plan view illustrated an exemplary embodiment of aspade-shaped assembly including an orientation handle;

FIG. 14B shows a cross-sectional view of the orientation handle takenalong a midline of the exemplary embodiment of the spade-shaped assemblyof FIG. 14A;

FIG. 14C is a close-up cross-sectional view of an area of the catheterhead of the shape-shaped assembly bounded by the circle shown in FIG.14B;

FIG. 15A is a side plan view illustrating an exemplary embodiment of acatheter head;

FIG. 15B is a cross-sectional view of the exemplary embodiment of thecatheter head illustrated in FIG. 15A;

FIG. 15C is a plan view of a distal end of the exemplary embodiment ofthe catheter head of FIG. 15A;

FIG. 16 illustrates an exemplary embodiment of a flexible needle withina curved catheter;

FIG. 17 is a close-up view of a distal portion of an exemplaryembodiment of a flexible needle similar to the needle illustrated inFIG. 16;

FIG. 18A is a side plan view of an exemplary embodiment of a trocarcatheter;

FIG. 18B is a side plan view of the trocar catheter of FIG. 18A with atrocar distal tip deployed;

FIG. 18C is a cross-sectional view taken along a midline of the trocarcatheter of FIG. 18A illustrating the trocar distal tip retracted intoan interior lumen;

FIG. 18D is a cross-sectional view taken along a midline of a proximalhandle of the trocar catheter of FIG. 18A and illustrates a plungermechanism;

FIG. 19A is a perspective view illustrating an exemplary embodiment of atrocar distal tip;

FIG. 19B is a close-up cross-sectional view of the trocar distal tip ina deployed configuration, e.g., as in FIG. 18B;

FIG. 19C is a close-up cross-sectional view of the trocar distal tip ina retracted configuration, e.g., as in FIG. 18C;

FIG. 20A illustrates an exemplary embodiment of an introducer systemsuitable for interventional cardiology procedures;

FIG. 20B illustrates the exemplary embodiment of the introducer systemof FIG. 20A in a configuration for puncturing tissue;

FIG. 20C illustrates the exemplary embodiment of the introducer systemof FIG. 20A with a guidewire being deployed through an inner lumen ofthe introducer system;

FIG. 21A is a perspective view illustrating an exemplary embodiment of athreaded introducer suitable for use during treatment of a dilated heartand/or functional mitral valve regurgitation;

FIG. 21B is a side plan view of the exemplary embodiment of the threadedintroducer illustrated in FIG. 21A;

FIG. 21C is a cross-sectional view taken along a midline of the threadedintroducer illustrated in FIG. 21A;

FIG. 22A is a perspective view illustrating illustrate an exemplaryembodiment of a suture cutter catheter suitable for use during medicaltreatment;

FIG. 22B is an internal side view of the exemplary embodiment of thesuture cutter catheter illustrated in FIG. 22A;

FIG. 22C is a cross-sectional view of a portion of the suture cuttercatheter illustrated in FIG. 22A;

FIG. 23A is a perspective view of an exemplary embodiment of a C-shapedpuncture location catheter/device suitable for use during medicaltreatment;

FIG. 23B is a side plan view of the exemplary embodiment of the C-shapedpuncture location catheter/device illustrated in FIG. 23A; and

FIG. 23C is a front plan view of the exemplary embodiment of theC-shaped puncture location catheter/device illustrated in FIG. 23A.

While the present disclosure is subject to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Theinvention should be understood to not be limited to the particular formsdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the present disclosure.

DETAILED DESCRIPTION

Various aspects of the present disclosure generally relate to systems,assemblies, apparatuses, devices, and methods for medical treatmentand/or treating heart conditions, including, by way of example, treatingdilation/dilatation (including a dilated left ventricle), valveincompetencies (including mitral valve regurgitation), and other similarheart failure conditions. The systems, assemblies, apparatuses, devices,and methods are adapted for a transcatheter medical treatments that maynot require full, open surgery, and can be minimally invasive. Eachapparatus or device disclosed herein preferably operates passively inthat, once placed in the heart, the device does not require an activestimulus, either mechanical, electrical, or otherwise, to function.Implanting one or more of the devices of the present disclosure operatesto assist in an apposition of heart valve leaflets so as to improvevalve function. In addition, the devices disclosed herein may either beplaced in conjunction with other devices that, or may themselvesfunction to, alter the shape or geometry of the heart, locally and/orglobally, and thereby further increase the heart's efficiency. That is,the devices disclosed herein generally facilitate an increased pumpingefficiency of the heart by way of an alteration in the heart's shape orgeometry and concomitant reduction in stress on heart walls, and throughan improvement in valve function.

The present disclosure offers numerous advantages over existingtreatments for various heart conditions, including valve incompetencies.The devices disclosed herein are relatively easy to manufacture and use,and the surgical techniques and tools for implanting the devices of thepresent disclosure do not require the highly invasive procedures ofcurrent surgical techniques. For instance, the treatments describedherein do not require removing portions of heart tissue, nor do theynecessarily require opening the heart chamber or stopping the heartduring operation. For these reasons, the treatments and techniques forimplanting the devices of the present disclosure convey a reduced riskto the patient as compared with other techniques. The less invasivenature of the treatments and techniques and tools of the presentdisclosure may further allow for earlier intervention in patients withheart failure and/or valve incompetencies. While often discussed hereinin terms of mitral valve treatments, the systems, devices, methods, etc.may be used to treat other heart valves, heart conditions, enlargementof other organs, etc.

In one embodiment, the present disclosure involves geometric reshapingof the heart and treating valve incompetencies. In certain aspects ofthe present disclosure, substantially an entire chamber geometry isaltered so as to return the heart to a more normal state of stress.Models of this geometric reshaping, which includes a reduction in radiusof curvature of the chamber walls, can be found in U.S. Pat. No.5,961,440 incorporated above. Prior to reshaping the chamber geometry,the heart walls experience high stress due to a combination of both therelatively large increased diameter of the chamber and the thinning ofthe chamber wall. Filling pressures and systolic pressures are typicallyhigh as well, further increasing wall stress. Geometric reshapingaccording to the present disclosure reduces the stress in the walls ofthe heart chamber to increase the heart's pumping efficiency, as well asto stop further dilatation of the heart.

Although the present disclosure is discussed in connection with treatingthe mitral valve of the heart, the present disclosure may be applied tovarious chambers of the heart and for other valves of the heart forsimilar purposes. More broadly, the systems, apparatuses, methods, etc.disclosed herein may be used in other applications to change thegeometries and/or stresses of other parts of the body (e.g., a stomach,bladder, or other part of the body). It also is contemplated that thepresent disclosure may be used to support an infarcted heart wall so asto prevent further dilatation, or to treat aneurysms in the heart. It isfurther contemplated that the present disclosure may be placed relativeto the heart without altering the shape of the chamber, and onlyaltering the shape of the valve itself.

In the following description, numerous specific details are set forth inorder to provide a thorough understanding of the present disclosure. Itwill be apparent, however, to one of ordinary skill in the art that theinvention disclosed herein may be practiced without these specificdetails. Thus, the specific details set forth are merely exemplary. Thespecific details may be varied from and still be contemplated to bewithin the spirit and scope of the present disclosure. In otherinstances, specific numeric references such as “first anchor” or “firstneedle” may be made. However, the specific numeric reference should notbe interpreted as a literal sequential order but rather interpreted thatthe “first anchor” or “first needle” is different from a “second anchor”or “second needle.” The term “coupled” is defined as meaning connectedeither directly to the component or indirectly to the component throughanother component. Further, as used herein, the terms “about,”“approximately,” or “substantially” for any numerical values or rangesindicate a suitable dimensional tolerance that allows the part orcollection of components to function for its intended purpose asdescribed herein.

In general, the present disclosure describes systems, apparatuses, andrelated methods for medical treatment, e.g., for treatment of heartdilation and any associated functional mitral valve regurgitation withina human heart and/or for transcatheter treatment. In one embodiment, ananchoring system or system for setting an anchor and/or splint maycomprise an anchor for fixating a mitral valve splint within the heart.In one exemplary embodiment, the anchor may comprise a cover supportedby a ring so as to assume a generally circular or disc-shapedconfiguration or other configuration to contact an exterior surface ofthe heart, the myocardium, or the pericardium. The system may include anultrasound probe for imaging parts of the system and parts of the bodyto be treated. The ultrasound probe may include a guide attached theretofor guiding various components/instruments of the system duringtreatment. The system may include a stabilizing assembly (e.g., aspade-shaped assembly) configured to be deployed in a right ventricle ofthe heart and to stabilize a catheter and/or assembly during penetratingthe septum. The stabilizing assembly may include various componentsincluding one or more of a catheter, catheter head, stabilizing wire orstructure (e.g., a spade-shaped wire), a curved needle, and an innerneedle. A curved, bent, or bendable needle may be loaded in the catheteras part of the spade-shaped assembly and may be configured to penetratea septum (e.g., the septum between the right ventricle and the leftventricle). Optionally, even if the stabilizing assembly is not used, acurved, bent, or bendable needle/catheter may still be used inessentially the same methods. The curved, bent, or bendableneedle/catheter may comprise a hollow tube having a multiplicity ofslits (e.g., S-shaped slits, C-shaped slits, V-shaped slits, zig zagslits, straight slits, parallel slits, diagonal slits, etc.) disposedalong the length of the needle. The slits (e.g., S-shaped slits) allowthe needle to undergo sharp turns within the heart. The curved, bent, orbendable needle may be configured to deploy an inner needle (or otherdevice) from a lumen of the curved, bent, or bendable needle and intothe left ventricle. The system may include a trocar catheter configuredfor puncturing body tissue (e.g., heart tissue) without damaging othernearby tissue.

The anchoring system or system for setting an anchor and/or splint mayinclude an introducer system or introducer assembly for interventionalcardiology procedures that may comprise an atraumatic/blunt shapeintroducer inside a needle catheter to protect nearby tissue within theheart during advancing a guidewire or other instrument through a lumenof the introducer. The system may include a threaded introducer, whichmay act as a temporary anchor and may be configured for advancing aguidewire and/or other instruments (e.g., the anchor or a deliverycatheter including the anchor) through a moving tissue, such as abeating heart. In an exemplary embodiment, the threaded introducercomprises a multiplicity of threads disposed along the length of thethreaded introducer and configured to rotatably engage with a tissue soas to facilitate advancing within the moving tissue as the threadedintroducer is rotated—the treaded catheter may enable the user tocontrol the depth of the tip of the threaded catheter in a moving organ(e.g., myocardium of a beating heart). The system may include a suturecutter catheter for cutting sutures in a remote, difficult to accesslocation, e.g., inside the heart or on a wall of the heart. The systemmay also include an ultrasound probe (e.g., a trans-vaginal ultrasoundprobe or other ultrasound probe may be used) for imaging parts of thesystem and parts of the body to be treated. The ultrasound probe mayinclude a guide attached thereto for guiding variouscomponents/instruments of the system during treatment.

FIGS. 1A-2B illustrate an exemplary treatment area/environment 100wherein a mitral valve splint is placed within a human heart 108. InFIGS. 1A and 1B, an exemplary mitral valve splint 104 is placed within ahuman heart 108 so as to lessen myocardial muscular stresses and treatleaflet apposition of a mitral valve 112, as discussed herein. FIG. 1Ais a vertical cross-sectional view of left ventricle 116 and rightventricle 120 of the heart 108 illustrating an exemplary orientation ofthe MV splint 104 within the heart 108. An alternative MV splint 105 isshown in outline. MV splint 105 may be similar to MV splint 104 ordifferent, but MV splint 105 is positioned with an anchor 141 againstthe septum 132 of the heart instead of outside the heart like anchor140. The exact placement and orientation of MV splint 104 and MV splint105 and their components may vary; the placements and orientations shownin FIGS. 1A-2B are non-limiting examples. Optionally, more than one MVsplint 104 could be used simultaneously at different locations of theheart for variations on the treatment.

FIG. 1B shows a transverse cross-sectional view of the left and rightventricles 116, 120 illustrating an orientation of the MV splint 104used in combination with a transventricular splint 124 (shown inoutline, but may be used simultaneously with MV splint 104 or othersplints described herein) for lessening myocardial muscular stresses andassisting in apposition of valve leaflets.

FIGS. 2A-2B illustrate another possible orientation and placement ofmitral valve splint 104 within a human heart 108 so as to lessenmyocardial muscular stresses and treat leaflet apposition of a mitralvalve 112, as discussed herein. FIG. 2A is a vertical cross-sectionalview of left ventricle 116 and right ventricle 120 of the heart 108illustrating an exemplary orientation of the MV splint 104 within theheart 108. FIG. 2B shows a transverse cross-sectional view of the leftand right ventricles 116, 120 illustrating an orientation of the MVsplint 104. Because the wall of the right ventricle is generally thinnerthan the wall of the left ventricle and because the blood pressure inthe right ventricle is generally lower than in the left ventricle, whenforce is applied to the right ventricle heart wall (e.g., when the MVsplint 104 is tensioned pulling anchors 136 and 140 toward each other),the wall or a portion of the wall of the right ventricle may becompressed inwardly or deformed, e.g., as shown in FIGS. 2A and 2B, andmay even be pushed into contact with septum 132. A lower placement ofanchor 140 along the right ventricle wall as shown in FIG. 2A may reduceissues associated with collapsing the right ventricle wall inwardly(e.g., this can leave the upper half of the right ventricle functioningnormally or better than if the upper portion of the right ventricle wasmore collapsed).

A superior anchor 136 is disposed at a first end of the tension member128 and positioned adjacent to the left ventricle 116. An inferioranchor 140 is disposed at a second end of the tension member 128 and maybe positioned adjacent to the right ventricle 120 (e.g., external to theheart outside the right ventricle as shown in FIGS. 1-2) or may bepositioned inside the right ventricle against a wall of the septum 132.Tension member 128 of the MV splint 104 extends from anchor 140 acrossthe right ventricle 120, through the septum 132, and across the leftventricle 116 of the heart to anchor 136. A primary function of the MVsplint 104 is to impart a shape change to an annulus of the mitral valve112, as well as advantageously reposition papillary muscles 144. Assuch, the tension member 128 may extend through the heart 108 superiorto the papillary muscles 144 and may be oriented primarily across themitral valve 112 and on or below the mitral valve annulus while avoidingkey vascular structures. Further details regarding specific treatmentsfor lessening myocardial muscular stresses and leaflet apposition of themitral valve, as well as devices and methods for delivering mitral valvesplints, are disclosed in U.S. Pat. No. 7,766,812, incorporated hereinabove.

FIGS. 3A-3B illustrate an exemplary embodiment of a self-expandableanchor 148 suitable for fixating the MV splint 104 within the heart 108,e.g., as described above. The self-expandable anchor 148 may comprise aring 152 which may peripherally support a cover 156. Upon cinching acentrally disposed tension member or cord 160, the cover 156 can assumea circular, flattened, disc-shaped, or pie-shaped configuration as shownin FIG. 3A, e.g., when the interior ends of the tabs 188 are pulledtoward the center, or can assume a cone shaped configuration if the endsof the tabs 188 are pulled in a direction perpendicular to a planealigned with the ring 152, e.g., when the tension member pulls theanchor toward another anchor.

It is contemplated that the self-expandable anchor 148 may be utilizedfor either or both of the superior and inferior anchors 136, 140.Optionally, different types of anchors may be used for the superior andinferior anchors (e.g., any of the anchors described in this disclosureor other types of anchors). A cover may or may not be used on one orboth of the superior and inferior anchor. As will be appreciated, thedeployed or expanded configuration (e.g.,circular/disc-shaped/pie-shaped/cone-shaped configuration) of theself-expandable anchor 148 shown in FIGS. 3A-3B is well suited foranchoring the tension member 128 in position within the heart 108, aswell as withstanding the forces encountered during changing the shape ofthe heart 108, as described above. In one embodiment, the deployed orexpanded configuration (e.g., circular, disc-shaped, pie-shaped, orcone-shaped configuration) of the anchor 148 (or other anchors describedelsewhere herein) may provide a surface area of substantially 4 cm²,which effectively eliminates migration of the anchor into the tissue ofthe heart 108. Optionally, the surface area may be between 2 cm² and 6cm² or between 3 cm² and 5 cm², though other sizes are also possible.Further, the anchor 148 may preferably be configured to withstand forcesdue to tension within the tension member 128 of up to substantially 17Newtons (N). A larger surface area helps the anchor withstand higherforces. For example, the embodiment shown in FIGS. 3A-3B can withstandforces of 17 Newtons with a surface area of 4 cm². As will beappreciated, the relatively large surface area of the cover 156 coupledwith the centrally disposed tension member 160 provide an inherentlystable configuration of the self-expandable anchor 148, therebyeliminating mechanical failures and migration into the tissue asencountered with other anchors. Further, the large surface area of thecover 156 and the centrally disposed tension member 160 cooperativelyoperate as a closure device which seals the punctures in the walls ofthe heart 108. In some embodiments, the cover 156 may be coupled with anadditional sealing component to further prevent bleeding through thepuncture site. The cover may be formed of a material that allows tissueingrowth into the material after implantation. Further, the cover may beformed to assume a generally cone-shaped configuration when placed undertension so as to inhibit migration of the anchor during beating of theheart (a cone shape is believed to be more stable, in terms ofmigration, than a flat shape).

As can be seen in FIGS. 3A-3B, the anchor 148 may transition between adeployed or expanded configuration (e.g.,circular/disc-shaped/pie-shaped/cone-shaped configuration) and acollapsed or low-profile configuration (e.g., a straightenedconfiguration) whereby the anchor may be loaded into a deliverycatheter. As can be seen in FIG. 3B, the tension member 160 may beloosened to allow the cover 156 to change from the deployed or expandedconfiguration (e.g., flattened/disc-shaped/pie-shaped/cone-shapedconfiguration) to a collapsed or low-profile configuration whereby thecover may be folded or compressed against the ring 152. Upon extendingor changing the ring 152 from a circular or ring-shaped configuration toa straightened configuration (and optionally folding the cover againstthe ring), the self-expandable anchor 148 may be loaded into a lumen ofa catheter 164 for delivery, (e.g., into the heart 108). During deliveryof the superior anchor 136 (e.g., anchor 148), the delivery catheter 164may be pushed through the walls of the heart 108 and navigated to asuitable location outside of the left ventricle 116. Some of the stepsdisclosed in U.S. Pat. No. 7,766,812, incorporated above, might also beused. Upon pushing the self-expandable anchor 148 out of the lumen ofthe delivery catheter 164, the ring 152 automatically changes from thestraightened or low-profile configuration to a deployed or expandedconfiguration (e.g., a circular configuration), as shown in FIG. 3B, inwhich the anchor 148 is transitioning between a low-profileconfiguration in the catheter 164 and a delivery, deployed, or expandedconfiguration.

After initial deployment of the anchor 148 from the catheter 164, thetension member or cord 160 may be pulled, which then draws the centralportion of the cover 156 taut toward the center of the ring 152, therebyproducing the deployed or expanded configuration (e.g., a circular,flattened configuration, a somewhat convex or cone like configuration,or the disc-shaped/pie-shaped configuration of the cover shown in FIG.3A). Tightening the tension member 160 pulls the self-expandable anchor148 against the exterior surface of the heart wall, the myocardium, orthe pericardium, such that the cover 156 assumes a convex or cone shapepressing against the surface and extending inward with the tensionmember 160 passing through the puncture in the heart wall. As thetension member may pull perpendicularly, generally perpendicularly(e.g., within 5 degrees of perpendicular), or at an angle away from aplane with which the ring of the deployed anchor is aligned (e.g., acircle of the ring is in the plane). A similar procedure may be utilizedfor deploying the self-expandable anchor 148 as the inferior anchor 140;however, the side of the heart having the inferior anchor is more easilyaccessible and a wider variety of anchors and procedures for deployingand securing the inferior anchor 140 may be used, e.g., the inferioranchor 140 may not need to assume as low a profile because it will notcross through the heart. In some embodiments, the tension member 160passing between the superior and inferior anchors 136, 140 may comprisethe tension member 128 shown in FIG. 1. Upon sufficiently tightening thetension member 160, one or more of the anchors 136, 140 may be drawninto convex cone shapes that point inward or toward each other so as tosuitably reshape the heart 108. The tension members described herein maybe cords, wires, cables, etc. and may be rigid, semi-rigid, or flexibleand may be elastic or non-elastic. An elastic tension member may allowsome give (e.g., expansion and contraction) during movement or beatingof the heart, whereas a non-elastic tension member may maintain the sameor substantially the same relative distance between the superior andinferior anchors. The tension members may optionally be braided orinclude a braided portion. The tension members may be formed of a highstrength/high performance polymers, e.g., UHMWPE, etc.

FIGS. 4A-4C illustrate an exemplary embodiment of the ring 152, whichmay be incorporated into the self-expandable anchor 148, in accordancewith the present disclosure. The ring 152 comprises a circularlyconfigured wire 168 having atraumatic ends 172 which meet at a break176. As will be appreciated, the break 176 facilitates expanding thering 152 into the low-profile configuration or straightenedconfiguration suitable for loading the ring 152 into the lumen of thedelivery catheter 164, as discussed above. The wire 168 may comprise orconsist of a shape memory material (e.g., nitinol or another shapememory alloy) suitable for returning the ring 152 from the low-profileconfiguration (e.g., straightened configuration) to the circularconfiguration shown in FIG. 4A. It is contemplated, however, thatvarious other suitably shape memory or elastic materials may be used forthe wire 168 without limitation, and without deviating beyond the spiritand scope of the present disclosure. In one embodiment, the ring 152 maybe formed of stainless steel. Ring 152 may be of different sizes,diameters, and shapes. Similarly, the wire 168 may be of differentsizes, diameters, and shapes, including in the cross-sectionalsize/shape of the wire 168. Optionally, the ring may be circular, oval,ovoid, flower shaped, star shaped, square, rectangular, pentagonal,hexagonal, decagonal, spiral, helical, and/or other shapes. Also, whilering 152 is shown having a circular cross-sectional shape, other crosssectional shapes are possible, e.g., oval, ovoid, triangular, square,rectangular, pentagonal, hexagonal, decagonal, etc.

The atraumatic ends 172 prevent the ends of the ring 168 from otherwisedamaging the delivery catheter, the tissues of the heart 108, or othernearby body tissues during delivery and deployment of the self-expandinganchor 148. Further, the atraumatic ends 172 facilitate loading theself-expanding anchor 148 into the interior lumen of the catheter 164.In one embodiment illustrated in FIGS. 4A-4C, the atraumatic ends 172comprise spherical portions or balls at the ends of the wire 168. In oneembodiment, the atraumatic ends 172 may be comprised of any of variousother suitably shaped portions as may be deemed appropriate; forexample, other shapes/configurations for the atraumatic ends 172 is alsopossible, e.g., cube-shaped, ovoid shaped, oval shaped, etc. In oneembodiment, the atraumatic ends 172 comprise portions of the ends of thewire 168 that are formed into spherical, generally spherical, ellipsoid,and/or ovoid portions. In one embodiment, the atraumatic ends 172 may becomprised of separate components that are fastened onto the ends of thewire 168. As will be appreciated, any of various techniques may be usedto fasten the atraumatic ends 172 onto the ends of the wire 168 withoutlimitation.

FIGS. 4D-4E illustrate an exemplary embodiment of a notched tube 150that may be incorporated into a manually expandable anchor (i.e., notself-expandable) that may be configured to operate similarly to theabove-discussed anchor 148. In a straight, low-profile configuration,shown in FIG. 4E, the notched tube 150 may comprise a multiplicity ofnotches 162, or cut-out portions, disposed along the length of the tube,such that the notched tube 150 comprises a series of straight andunbroken sections 154. Each of the notches 162 may be wedge-shaped orcomprise a wedge-shaped portion extending partially across the diameterof the tube so as to enable bending adjacent straight sections 154toward one another. The multiplicity of notches 162 may enable thenotched tube 150 to be pulled or transitioned from a low profileconfiguration (e.g., straightened or flattened configuration) as shownin FIG. 4E to an expanded or deployed configuration (e.g., a circular,ring-like, or decagonal, etc. configuration as shown in FIG. 4D).

A wire, member, or cable 174 disposed within a lumen of the notched tube150 may enable changing the tube from a low-profile configuration (e.g.,straight or flattened configuration) as shown, for example, in FIG. 4Eto an expanded configuration (e.g., a circular, ring-like, decagonal,etc. configuration) as shown, for example, in FIG. 4D. In the deployedor expanded configuration (e.g., a circular, ring-like, decagonal, etc.configuration), the notches 162 may be substantially closed (e.g., withadjacent faces of wedge shaped notches brought close together or incontact) and each pair of adjacent straight sections 154 may be disposedat an angle with respect to one another and share an intervening bend158. It is contemplated that the overall diameter of the notched tube150 in the circular configuration may depend upon the number and lengthof straight sections 154, the number of notches 162 disposed along thetube, and the depth to which the notches 162 extend across the diameterof the tube. It should be understood that the number and length ofstraight sections 154, and the number and depth of the notches 162 maybe varied without limitation.

The notched tube 150 may comprise atraumatic ends 166. The atraumaticends 166 may be configured to prevent the ends of the notched tube 150from damaging a delivery catheter, the tissues of the heart 108, orother nearby body tissues during delivery and deployment of the notchedtube 150 to an anchor site, as described herein. The atraumatic ends 166further facilitate loading the notched tube 150 into the interior lumenof a catheter, such as, for example, the catheter 164. In oneembodiment, the atraumatic ends 166 may be comprised of smooth, roundededges of the notched tube 150. In one embodiment, the atraumatic ends166 may be comprised of any of various suitably shaped portions as maybe deemed appropriate; for example, other shapes/configurations for theatraumatic ends 166 may be comprised of spherical portions, balls,cube-shaped, ovoid shaped, oval shaped, etc. In one embodiment, theatraumatic ends 166 may comprise portions of the ends of the notchedtube 150 that are formed into spherical, generally spherical, ellipsoid,and/or ovoid portions. In one embodiment, the atraumatic ends 166 may becomprised of separate components that are fastened onto the ends of thenotched tube 150. Any of various techniques may be used to fasten theatraumatic ends 166 onto the ends of the notched tube 150 withoutlimitation. In the deployed or expanded configuration (e.g., as shown inFIG. 4D), the atraumatic ends 166 may meet at a break 170.

FIGS. 5A-5C illustrate an exemplary embodiment of the cover 156 whichmay be incorporated into the self-expandable anchor 148, according tothe present disclosure. FIG. 5A illustrates the cover 156 in an open,unfolded configuration wherein the cover 156 is comprised of a strip 180of suitable material having a first, straight edge 184 and a second edgecomprising a series of tabs 188. An intermediate portion of strip 180may include triangular or wedge shaped portions 190 that work togetherto fill the center of the anchor, e.g., in pie-shaped slices. Thetriangular or wedge-shaped portions 190 can help prevent excessivematerial in the center of the anchor and, thus, help prevent excessivefolding or bunching of the material when in the anchor's fully deployedconfiguration. This may also help the anchor and cover assume a moreflattened configuration. Other shapes and designs for the cover are alsopossible. For example, the cover may have a larger, unbroken surfacearea (e.g., cover 156 may not have as many tabs, triangular or wedgeshaped portions, or spaces as shown in FIGS. 3A & 5B). Cover 156 may beconstructed of a thick material or a thin material, and may fill all ora portion of the center of the anchor. The material comprising the strip180 may be formed of one or more of any of various polymer materials,such as polyethylene terephthalate (PET), ultra-high-molecular-weightpolyethylene (UHMWPE), and/or other similar material. In one embodiment,the strip 180 may comprise one or more of any of a wide variety ofsuitable metallic materials. In one embodiment, the strip 180 maycomprise a non-metallic material, such as by way of non-limitingexample, carbon fibers and the like. Various combinations of the abovematerials may also be used.

As illustrated in FIGS. 5B-5C, portions of the strip 180 may be foldedand secured such that loops are formed through which the ring or tensionmember may be threaded to form the anchor. For example, the straightedge 184 may be folded onto (e.g., to overlap) a mid-region of the strip180 to form an overlapping region 185 in which the edge 184 isattached/adhered/sewn to a portion of the mid-region and to form apassage 192 extending along the length of the straight edge. Similarly,each tab 188 may be folded over to form a loop 196. As best illustratedin FIG. 5C, the passage 192 comprises a diameter suitable to receive thering 152, and the loops 196 comprise a diameter suitable for receivingthe tension member 160. Optionally, a similar cover, similar strips, orportions/segments of a cover could be formed from double lumen cloth(e.g., that may come with a small lumen/passage on one end and a largerlumen/passage on the other end), or from tube-shaped cloth. If tubeshaped cloth is used, it could be flattened with sutures but leavelumens/passages on the ends and could result in the same or a similarshape. Double lumen cloth or tube shaped cloth could be much strongerthan a cloth end that is folded and adhered/attached, because theadhesion or attachment could be weakened or be more likely to open.

The self-expandable anchor 148 may be formed by mounting the cover 156onto the ring 152 by way of threading the ring 152 through the passage192, and by threading or weaving the tension member 160 through all ofthe loops 196. The tension member may optionally be tied to itself in aslip knot or similar adjustable knot that allows the tension member tocinch the loops 196 toward the center of the ring. Optionally, afterpassing through the loops 196, each end of the tension member may extendto a proximal end of the delivery catheter and pulling at one or bothends may cinch the loops 196 toward the center of the ring. As will beappreciated, upon loosening the tension member 160 within the loops 196,the strip 180 facilitates expanding or transitioning the ring 152 from adeployed or expanded configuration (e.g., a circular or ring-shapedconfiguration) into a low profile configuration (e.g., straightenedconfiguration), as discussed above, and thus enables the self-expandableanchor 148 to be suitably loaded into the lumen of the catheter 164.

It should be recognized, however, that the anchor 148 need not belimited to the ring 152 and cover 156, but rather various otherconfigurations of anchors are contemplated within the scope and spiritof the present disclosure. For example, FIGS. 6A-11B illustrate variousexemplary embodiments of anchors according to the present disclosure. Inparticular, FIG. 6A illustrates an exemplary embodiment of an anchor 200comprising a ring 204 attached to a tension member 208 by way of amultiplicity of spokes 212. The ring 204 may include features the sameas or similar to ring 152 (including having a break and atraumatic ends,and being transitionable to a low profile or a straightenedconfiguration) described above and/or may include different designfeatures or characteristics (e.g., forming an unbroken ring). If thering 204 includes a break, it may be delivered in the same or a similarway to ring 152 as described above and elsewhere herein. If formed as anunbroken ring, the ring 204 may be capable of having two sides collapsedtogether to form a narrow or low profile of the anchor that may beinserted in a delivery catheter, and may be deployed out of a deliverycatheter.

Ring 204 is depicted in FIG. 6A as having a larger cross-sectional sizethan ring 152, but other sizes are also possible, including sizes with across-sectional diameter less than ring 152. Also, while ring 204 isshown having a circular cross-sectional shape, other cross sectionalshapes are possible, e.g., oval, ovoid, triangular, square, rectangular,pentagonal, hexagonal, etc. In one embodiment, ring 204 may beconfigured as a cylinder or cylindrical ring. During use, pulling thetension member 208 may place the cylinder or cylindrical ring in contactwith the exterior surface of the heart 108, the myocardium, orpericardium while the tension member 208 passes through the center ofthe cylinder or cylindrical ring and the puncture in the heart wall, asdescribed above.

While spokes 212 are depicted in place of a cover in FIG. 6A, a covermay also be used (e.g., to cover the ring and spokes or to cover aportion of the ring and spokes), or a cover may be used instead of thespokes 212. The cover may be the same as or similar to the cover 156described above and/or may be constructed of a similar material to cover156. Optionally, the cover may have a larger, unbroken surface area(e.g., the cover may not have any many tabs, triangular or wedge shapedportions, or spaces between tabs as cover 156). In one embodiment, thecover may be an unbroken material that covers the entire ring and/or anyspokes, or the cover may be unbroken except for a hole in its center toallow tension member 208 to pass therethrough. The cover may beconstructed of a thick material or a thin material, and may fill all ora portion of the center of the anchor. The cover may be disc-shaped,pie-shaped, or another shape, and may be broken or unbroken. The covermay connect ring 204 to tension member 208.

The tension member 208 may include features the same as or similar totension member 160 described above and/or may include different designfeatures or characteristics. The spokes 212 may comprise short segmentsof cord, wire, ribbon, or other material that are tied to the ring 204and the tension member 208. The material of the spokes may be the sameas that used for the cover 156 or tensioning member 160, and may be PET,UHMWPE, PTFE, ePTFE, or other suitable polymers or materials. More orfewer spokes may be used than are shown in FIG. 6A. In one embodiment,3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 spokes may be used. Anchor 200 mayadditionally (or, optionally, as an alternative to the spokes) includeribbons of a material woven and/or attached to the ring 204 and/or thespokes 212. The ribbons of material may provide a greater contactsurface area and may provide additional strength and ability for theanchor to withstand high tension forces, e.g., when implanted. Theribbons of material may be similar to ribbons 308 shown in FIG. 6C. Theribbons of material may be formed of PET, UHMWPE, PTFE, ePTFE, or othersuitable polymers or materials. Operation of the anchor 200 may besimilar to the operation of the self-expandable anchor 148, buttightening the tension member 208 cinches the spokes 212 toward thecenter of the ring and draws the anchor 200 against the exterior surfaceof the heart 108.

Optionally, an inner ring or hub may be used near the center of the ring204, and spokes 212 may extend and attach between the ring 204 and theinner ring or hub. During deployment of the anchor, pulling the tensionmember may cause the inner ring or hub, the spokes 212, and the ring 204to lay against the exterior+− surface of the heart 108, as describedherein. The inner ring or hub may be constructed of a material the sameas or similar to those used for the ring 152 or the tension member 160or may be constructed of a different material (e.g., may be a metal orsteel ring). The spokes may wrap around or through the ring or may beotherwise attached/connected.

FIG. 6B illustrates an exemplary embodiment of an anchor 276, accordingto the present disclosure. The anchor 276 comprises a cover 280 disposedover a ring 284. A tension member 288 may be connected to the cover 280and/or the ring 284. The ring 284 may include features the same as orsimilar to one or more of the other rings (e.g., rings 152, 204)described herein. The cover 280 may include features the same as orsimilar to one or more of the other covers described herein (e.g., cover156). The tension member 288 may include features the same as or similarto one or more of the other tension members described herein (e.g.,tension members 160, 208). The anchor 276 may include a central anchoror hub 292. The circular cover 280 may be attached to tension member 288by way of central anchor or hub 292. The anchor 276 may functionsimilarly to the self-expandable anchor 148 or anchor 200. Pulling thetension member or cord 288 may place the circular cover 280 and the ring284 into contact with an exterior surface of the heart 108, themyocardium, or pericardium. Among other things, the central anchor orhub 292 may provide additional support and may help seal the puncture inthe exterior surface or wall of the heart.

FIG. 6C illustrates an exemplary embodiment of an anchor 332. Anchor 332may include ribbons 308 (e.g., PET ribbons), spokes 324, and/or ring336. The ring 336 is shown as circular in FIG. 6C, but may be formed inother shapes, e.g., ring 336 may be formed as a flower-shaped ring, astar-shaped ring, oval ring, a square ring, a pentagonal ring, ahexagonal ring, etc.) The ring 336 may function in the same or similarway to the anchors and rings discussed above, e.g., the ring 336 maychange to a low profile configuration in the same/similar way or adifferent way from the anchors and rings discussed above. For example,the ring 336 may optionally include a break and/or atraumatic endssimilar to those described above with respect to ring 152 and may beconfigured to allow the ring 336 to be transitioned between alow-profile configuration and a deployed configuration similar to ring152. Optionally, the ring may function in other ways, e.g., the ring 336may transition to a lower profile by the sides being compressedtogether, bent, or folded. Optionally anchor 332 may include an innerring or hub 328, which may be the same as or similar to the inner ringor hub discussed above. Optionally, a tension member may thread throughthe ribbons 308 or a portion of the ribbons and cinch them toward thecenter when tightened, e.g., in a similar way to that discussed abovewith respect to the embodiment shown in FIGS. 3A and 3B.

The ring 336 may be connected to a tension member directly or may beconnected indirectly by connecting to a cover, spokes, ribbons, or aninner ring or hub that connects to the ring 336. The anchor 332 mayinclude a cover and/or spokes that are the same as or similar to thecovers 156 or 280 or spokes 212 described above. Optionally, the anchor332 may include one or more than one ribbon 308 (e.g., a PET ribbon)wound and/or woven to parts of the anchor 296 in various patterns, e.g.,in a star-shaped, flower-shaped, triangular, square, pentagonal, orhexagonal pattern. One or more than one ribbon 308 may be woven togetherand/or woven to the ring 336 so as to form an anchor surface suitablefor contacting an exterior surface of the heart 108, the myocardium, orpericardium. More surface area may be created by the ribbons 308 thanthat shown in FIG. 6C. When in contact with the exterior surface, thetension member 304 may pass through the puncture(s) in the exteriorsurface and heart wall. The ribbons of material may also strengthen theanchor 332 and improve its ability to withstand high tension forces,e.g., when implanted.

FIG. 7A illustrates an exemplary embodiment of an anchor 202 comprisingan expandable balloon 206 (while a “balloon” is describe, thisencompasses use of a cover, e.g., a pouch cover) that is attached to atension member 208. The expandable balloon 206 (may be made from any ofvarious medically-approved textiles, such as, by way of non-limitingexample, PET, UHMWPE, PEEK, cloth, PTFE, and the like. It iscontemplated that the expandable balloon 206 may be comprised of anymaterial that exhibits one or more desirable material properties, suchas a suitable tensile strength, facilitates tissue response and/or cellgrowth, enables an easy and durable connection with the tension member208, facilitates a relatively low crimping profile, etc. The expandableballoon 206 may further comprise one or more sutured structures/patterns210. The sutured structures/patterns 210 may be in a variety of sizesand shapes, e.g., they may include curved or straight lines forming oneor more of a variety of patterns on the top, bottom, sides, or more thanone of these of the balloon. In one embodiment, the suturedstructures/patterns 210 may comprise a flat structure wherein straight,curved, partially curved, etc. non-planar suture lines are used to forma pattern on top, sides, and/or bottom of the expandable balloon 206.FIG. 7A shows some exemplary suture structures/patterns 210. In oneembodiment, a curved, or partially curved, non-planar suture line mayadvantageously increase the tensile strength and decrease the crimpingprofile of the expandable balloon 206. In one embodiment, one or moreplanar suture lines may be used to form a 2D or 3D structure on top ofthe expandable balloon 206, without limitation.

In some embodiments, the expandable balloon 206 may be configured to befilled with a filler material 242 so as to occupy an interior volume ofthe balloon, or a portion of the interior volume of the balloon, suchas, by way of non-limiting example, a circumflex area of the expandableballoon 206. The filler material 242 may be comprised of any materialfound to be suitable for occupying the interior volume of the balloon,such as, but not limited to, liquid, a liquid that fixates over time(e.g., an epoxy), flexible coils, one or more rings (e.g.,self-expandable or manually expandable), mini-spheres or micro-spherescomprised of metal or plastic, other fillers that may be delivered to aballoon via a relatively narrow tube, and a combination of one or moreof these. The material may be of a liquid, gaseous, metal, polymer,cloth, or other material. For example, in one embodiment, illustrated inFIG. 7D, an anchor 238 may be filled with a filler material 242 in theform of a wire filler or coil (e.g., this may be similar to the conceptof a coil that is used to fill and treat an aneurism) and may bedisposed between the myocardium 248 of the heart 108 and the pericardium250. In one embodiment, partial filling may be achieved by using aNitinol wire to form a spiral shape at the balloon circumflex area. Inone embodiment, the filler material may be comprised of metal or plasticspheres having a diameter of substantially 1.5 millimeters (mm) (thougha variety of diameters are possible, e.g., 0.1-3 millimeters, 0.5-2millimeters). It is contemplated that mini-spheres or micro-spheresadvantageously provide an optimal spatial arrangement within theinterior volume of the expandable balloon 206.

Various delivery and filling devices and techniques may be used todeliver the anchor 202 and to deliver one or more of a variety of fillermaterials to the balloon or filling space of the balloon. In oneembodiment, the anchor 202 and/or balloon 206 may be delivered using adelivery catheter. The anchor 202 and/or balloon 206 may be containedwithin a lumen of the delivery catheter until it arrives at a locationfor deployment (e.g., a posterior wall of a left ventricle) and may beexpanded out of the lumen to an expanded or deployed configuration usinga filler material, preliminary inflation fluid or material, and/or apushing device. In one embodiment, the balloon may assume a low profilearound an outer wall of an end of a delivery catheter during deliveryand be expanded away from the outer wall upon arriving at the deploymentlocation. In one embodiment, a stylet, pushing device, ring, etc. may beused to extend the balloon forward into a stretched, elongatedconfiguration (e.g., similar to balloon 258 as shown in FIG. 8A) thathas a reduced diameter for delivery, e.g., a stylet could be pushedthrough a lumen of a delivery catheter and extended until it pushes adistal end of the balloon forward and stretches it to a lower diameterprofile.

FIGS. 7B-7C illustrate an anchor 214 comprising an expandable balloon206 disposed in filling configurations wherein an interior 218 of theexpandable balloon may be filled with a filler material (e.g., a liquid,flexible coil, spheres, or other material). As can be seen in FIG. 7C,the expandable balloon 206 may be placed into fluid communication with afilling catheter or tube 222, and the balloon may be attached to thefilling catheter/tube 222. This attachment or connection may be by wayof a spring 226, clamp, stent, or other fastening device or mechanism.The expandable balloon 206 preferably is attached to the fillingcatheter/tube 222 such that the balloon is suitably sealed to thefilling catheter/tube during the filling process and may be controllablyremoved from the filling catheter 222 after the filling process. In oneembodiment, the spring 226 may be comprised of a nitinol spring or otherdevice that is shape-set to an inner diameter that is smaller than theouter diameter of the filling catheter 222. The spring 226 may betwisted around a sleeve portion 230 of the expandable balloon 206. Afterthe filling process is finished, an external pusher 234 may be advancedto push the spring 226 and the sleeve portion 230 away from the fillingcatheter 222. In absence of the filling catheter 222, the spring 226 orother attachment device may return to a smaller (e.g., a shape-set)dimension or inner diameter and press the sleeve portion 230 closed toseal the interior 218 of the expandable balloon 206. The fillingcatheter/tube 222 may act as a delivery catheter as well (see discussionof delivery catheters herein) to deliver the anchor and/or balloon tothe desired location.

In general, the filler material may be delivered to the fillingcatheter/tube 222 by way of various deliver devices or mechanisms. Inone embodiment, magazines of filler material may be easily attached toand detached from a main delivery system. In some embodiments, two ormore filling catheters/tubes (e.g., two filling catheters/tubescomprising a curved tip) may be used for filling (e.g., symmetricallyfilling) of the interior 218. In one embodiment, wherein the fillermaterial comprises a wire or coil (e.g., a nitinol wire), a shapedfilling catheter comprising two curved tips may be used to insert thenitinol wire into the interior 218 at a 90 degree (or 60-120 degree)turn with respect to the shaft or longitudinal axis or the shapedfilling catheter. In one embodiment, the shaped filling catheter/tubemay comprise two curves, or may comprise two single curved filling tubeslocated at a 180-degree angle relative to one another.

FIGS. 8A-8B illustrate an exemplary embodiment of an expandable anchor254 (which may be self-expandable, partially self-expandable, ormanually expandable) comprising an expandable balloon 258 (while a“balloon” is described this encompasses a cover, e.g., a pouch of clothor other material, or similar concepts can be used with one of thecovers described elsewhere herein), and an internal ring 262 (e.g., awire ring) that may be crimped into a low profile configuration suitablefor being delivered and/or deployed from inside a catheter. The ring 262may be comprised of a shape memory material, such as a shape memoryalloy, nitinol, or another similar material that, when deployed, changesthe expandable balloon 258 (and/or a cover) to an expanded configurationof the expandable anchor 254 (e.g., as illustrated in FIG. 8B). In oneembodiment, the ring 262 may be attached to the expandable balloon 258(and/or a cover) by way of an internal groove, one or more sutures,loops, and/or other means, such that the ring is folded into an elongateshape or a saddle-shape during crimping into the low profileconfiguration of FIG. 8A. In one embodiment, if a cover similar to cover156 (e.g., as used in FIG. 3A) is used, a ring may be crimped fordelivery and expand in a similar way to ring 262 to expand the cover156. It is contemplated that a balance between a small wire diameter toallow elastic deformation at low crimping profiles and a sufficientopening force to expand the balloon 258 should be maintained. As such,in one embodiment, the ring 262 may be comprised of multiple loops of asingle wire. In one embodiment, the ring 262 may be comprised ofmultiple separate rings that are connected by sutures such that therings form a uniform structure after expanding. In some embodiments, thewire(s) comprising the ring 262 may be comprised of circular orrectangular wire. In some embodiments, an expandable frame may bedisposed inside the expandable balloon 258. The expandable frame may besutured to the expandable balloon 258 or may be deployable after theballoon so as to reduce crimping profile. The expandable frame may becomprised of nitinol braiding, laser cut tube, or other suitablecomponents.

In some embodiments, the expandable balloon 206 or expandable balloon258 may be temporarily expanded to restore its shape after beingdeployed in the crimped, low-profile configuration shown in FIG. 8A. Inone embodiment, temporary expanding of the expandable balloon 206 or 258may be achieved by inflating a smaller balloon inside the expandableballoon 206 or 258 to aid in returning the expandable balloon to theexpanded configuration shown in FIG. 8B. In some embodiments, whereinthe expandable balloon 258 comprises a sealed structure or a coating(e.g., that is fluid tight), the expandable balloon 258 may be filledwith saline or other suitable fluid to restore the shape of theexpandable balloon after being deployed. In some embodiments, a nitinolstructure may be inserted into the expandable balloon 258 by way of acatheter so as to restore the expandable balloon to the expandedconfiguration after deployment.

FIG. 9A illustrates an exemplary embodiment of anchor 340 which isparticularly well suited for use as the superior anchor 116 inaccordance with the present disclosure, but may optionally be used asthe inferior anchor 140. FIG. 9A depicts anchor 340 as a cone-shapedanchor, but it could also be other shapes, e.g., a cylindrical shape,helical shape, etc. FIG. 9B is a cross-sectional view taken along amidline of the coiled anchor 340. The coiled anchor 340 generallycomprises several turns of a coiled wire 344. In one embodiment, thediameter of the coil decreases as it transitions from a base portion 348to a top portion 352. As best illustrated in FIG. 9B, the anchor 340 iscone-shaped so long as a difference in diameter of adjacent turns of thecoil is less than the diameter of the wire comprising the coiled wire344, or D1−D2>d with reference to FIG. 9B. Once deployed into the heart108, the tension member or cord 160 may be affixed to the top portion352 and pass through the center of the coils with the base portion 348pulled into contact with the exterior surface of the heart. The coiledanchor generally provides a relatively stiff anchor possessing a largearea of contact with the surface of the heart 108. The coiled wire 344preferably is comprised of a shape memory material, such as nitinol, ashape memory alloy, or other similar material. The coiled wire 344 maybe covered with a cover (e.g., a fabric or tissue suitable fordeployment in the heart 108 and/or for tissue ingrowth). The cover maybe formed of the same or similar materials to the covers discussedabove. It is contemplated that the coiled anchor 340 may be producedwith a degree of pre-tension so as to provide an advantageous level ofanchoring in severe deployment conditions. It is further contemplatedthat in some embodiments, the anchor 340 may be practiced without adecrease in coil diameter, such that the anchor is cylindrically-shaped,e.g., D1=D2 and so forth.

FIG. 10A illustrates an exemplary embodiment of a telescope-shaped,coiled anchor 356, according to the present disclosure. FIG. 10B is across-sectional view taken along a midline of the telescope-shapedanchor 356. The telescope-shaped anchor 356 is substantially similar tothe cone-shaped, coiled anchor 340 and may include the same or similarfeatures; however, the telescope-shaped anchor 356 comprises a wire coil360 wherein the difference in diameter of adjacent turns of the coil isgreater than the diameter of the wire, or D1−D2>d as shown in FIG. 10B.Thus, the telescope-shaped anchor 356 provides a large area of contactwith the surface of the heart 108; and in the case of extreme tension ofthe tension member or cord, the area of contact increases, whichadvantageously decreases contact tractions and provides for strongeranchoring.

FIG. 11A illustrates an exemplary embodiment of a floor-like, coiledanchor 364, which can be used, for example, as the superior anchor 116.FIG. 11B is a cross-sectional view taken along a midline of the anchor364. The anchor 364 is similar to the coiled anchors illustrated inFIGS. 9A-10B and may include the same or similar features; however, theanchor 364 shown in FIGS. 11A-11B comprises a wire coil 368 which iswound so as to form a lower level 372 and an upper level 376. The lowerlevel or base portion 372 provides a relatively large area of contactwith the exterior surface of the heart 108 while also preventing theupper level or top portion 376 and the tension member or cord 160 frombeing drawn under tension into the puncture in the wall of the heart108. Although the illustrated embodiment of the floor-shaped anchor 364comprises a two-level structure, it is contemplated that in someembodiments, the floor-shaped anchor may comprise more than two-levels,as deemed appropriate.

It is contemplated that each of the coiled anchors shown in FIGS. 9A-11Band/or discussed above may be used as a superior and/or inferior anchor.It is further contemplated that these anchors may be used in similarmethods and/or delivered and deployed in a similar manner to the anchorshown in FIGS. 3A-3B or other anchors described herein. For example, thecoiled anchors may be formed of a shape memory material or alloy (e.g.,nitinol) and may be transitioned to a low profile (e.g., a straightenedor substantially straightened configuration) to be loaded into adelivery catheter. The coiled anchors may be delivered to a desiredlocation inside a delivery catheter, then deployed out of the deliverycatheter. When deployed, the coiled anchors may transition automaticallyfrom the straightened or low profile configuration back to theirdeployed configuration, e.g., the coiled configurations shown in FIGS.9A-11B. Thus, these may also be considered self-expanding anchors.Optionally, the anchors could be manually expandable, or only partiallyself-expandable as well. Optionally, any of the anchors described hereincould be deployed surgically or with minimally invasive surgery to aside of the heart without first passing through the heart.

Moreover, the anchors shown in FIGS. 9A-11B need not be limited to wirecoils having circular wire patterns, but rather any of the wire coilsshown in FIGS. 9A-11B may comprise a non-circular wire pattern, such as,by way of non-limiting example, rectangular, square, triangular,pentagonal, hexagonal, oval, ovoid, ellipsoid, as well as any othersuitable shape, e.g., each turn of a coil may have one of these shapesand each turn of the coil may be the same or different shapes.Similarly, the coiled wires comprising the anchors shown in FIGS. 9A-11Bneed not be limited to wires having circular cross-sectional shapes. Forexample, in some embodiments the cross-sectional shape of the wires maybe oval, ovoid, ellipsoid, flower shaped, star shaped, triangular,square, rectangular, pentagonal, hexagonal, as well as any othersuitable shapes without limitation.

FIGS. 12A-15C illustrate an exemplary embodiment of an assembly 380 foruse with an anchoring system, according to the present disclosure. Theassembly 380 is depicted as a spade-shaped stabilizing assembly, butother shapes are possible and, in one embodiment, the wire spade portioncould be omitted. The assembly 380 can be used as a septum-punctureassembly to puncture a septum between portions (e.g., ventricles) of theheart, and may be used as a stabilizing assembly to stabilize a portionof the assembly or a puncturing instrument for puncturing the septum.The assembly 380 generally is configured to be deployed in the rightventricle 120 of the heart 108 at a distal end of a catheter 384. Asillustrated in FIGS. 12A-12B, the assembly 380 may comprise a wire spade388, an outer needle 392, an inner needle 400, a catheter head 396,and/or a catheter 384. The catheter 384 may be considered part of thespade-shaped stabilizing assembly 380 or may be considered a separatecomponent to which a wire spade or spade-shaped assembly may attached.The catheter 384 could, optionally, be a directional catheter that cantransition between a straight configuration and a bent or angledconfiguration (e.g., at a 90 degree or other angle). Wire spade 388 andneedle 392 may be connected to the catheter 384 by way of a catheterhead 396. The wire spade 388 may be configured to be received into theright ventricle 120 and provide stability to the spade-shaped assembly380 while the needle 392 penetrates the septum 132 between the rightventricle and the left ventricle and enters the left ventricle.

The needle 392 may be curved as shown in FIGS. 12A-14B, or the needle392 may be a different shape (e.g., form a right angle) and/or may bebendable/transitionable (e.g., movable between a straight configurationand a bent or angled configuration). Optionally, needle 392 may include,within a lumen of the needle 392, an inner needle 400. The inner needle400 may also be curved and/or flexible and may be configured to beadvanced from the lumen of the curved needle 392 across the leftventricle 116 and puncture the posterior wall of the left ventricleafter the curved needle 392 has passed through the septum 132. One, morethan one, or all of the wire spade 388, the curved needle 392, and theinner needle 400 may be comprised of a shape memory material, such asnitinol, a shape memory alloy, or other similar material, and may beconfigured so as to assume the shapes shown in FIGS. 12A-12B.Optionally, these may be configured to assume other shapes as well; forexample, the wire spade 388 may be configured to have a more circular,triangular, rectangular, square, or other shape. Further, the wire spade388 (e.g., as used in FIGS. 12A-12B or elsewhere herein) may becomprised of multiple branches or more than one shaped wire; forexample, the wire spade 388 may be comprised of a first wire 382 and asecond wire 386 (or more wires) that are coupled with the catheter head396, e.g., as shown in FIG. 12C. The first and second wires (or one,two, three, four, etc. separate wires) may form a wire spade withmultiple branches (e.g., four branches as shown in FIG. 12C). The firstand second wires 382, 386 or multiple branches of one or more wires maycooperate to stabilize the assembly 380 within the right ventricle 120while the needle penetrates the septum 132, as described with respect toFIGS. 12A-12B. It is contemplated that the first and second wires 382,386 may be particularly well suited to stabilize the assembly 380 inright ventricles 120, even large right ventricles. The embodiments ofthe wire spade 388 illustrated in FIGS. 12A-12C may be collapsible to alower profile shape or configuration for less invasive or traumaticinsertion into the right ventricle, then expand to an expanded shapethat stabilizes the assembly 380 in the right ventricle, e.g., duringpenetration of the septum with the needle 392.

The embodiments of the wire spade 388 illustrated in FIGS. 12A-12C maycomprise a shape and size suitable for contacting one or more interiorsurfaces of a heart (e.g., a right ventricle 120, or other chamber)while supporting the needle 392 such that it can penetrate the septum atsubstantially a 90-degree angle (or another angle, e.g., between 45 and145 degrees or between 70 and 120 degrees) relative to the wire spade orthe catheter. The angle of the tip of the needle 392 relative to thecatheter 384 or wire spade 388 may increase or decrease with anincreasing distal extension of the needle beyond the catheter head 396,e.g., if curved, the further curved needle 392 extends from the catheter384, the angle the tip of the curved needle 392 points may changerelative to the catheter 384 or wire spade 388. The angle of the tip ofthe curved needle 392 illustrated in FIG. 12A is substantially 145degrees. As shown in FIG. 13, the radial angle of the curved needle 392is substantially 90 degrees. A variety of other angles are also possibleincluding, without limitation, in the range from 45 to 145 degrees, from70 to 120 degrees, or from 80 to 100 degrees. Generally, the anglebetween the tip of the curved needle 392 and the wire spade 388 and theangle between the tip of the curved needle 392 and the catheter 384 maybe controlled by a surgeon by way of an orientation handle 404. As shownin FIGS. 14A-14B, the orientation handle 404 may be located at aproximal end of the catheter 384 and comprises a handle and controlswhereby the surgeon may operate the spade-shaped assembly 380 orcomponents of the spade-shaped assembly, e.g., to extend, retract,rotate, and/or change the orientation of the curved needle 392 and/orthe inner needle 400.

FIG. 14C shows a close-up cross-sectional view of an area of thestabilizing assembly 380 bounded by the circle shown in FIG. 14B, andshows one exemplary embodiment of how components of the stabilizingassembly 380 may be coupled, combined, and/or attached. Wire spade 388is attached on one end with its ends inserted into the catheter head396. The opposite end shows an example of how the catheter 384 may beattached to the catheter head. A connecting tube 386 may be used toconnect to the catheter 384 and a wrapping tube 390 may be positionedover the connecting tube 386 and a portion of the catheter 384 to helphold these together. While a variety of materials may be used, in oneembodiment the connecting tube 386 is formed of nitinol and the wrappingtube 390 is a braided tube. Wrapping tube 390 may also be a shrink wraptube. Other ways of connecting the catheter 384 to the catheter head 396may also be used. Optionally, no connecting tube 386 may be used and thecatheter 384 may extend into the catheter head 396, e.g., in place ofconnecting tube 386. Optionally, no wrapping tube 390 may be used andcatheter 384 may be directly adhered, bonded, or otherwise connected tothe inner wall of catheter head 396.

FIGS. 15A-15C illustrate detailed views of a catheter head 396 that maybe used as part of the spade-shaped assembly 380. As best shown in FIG.15A, the catheter head 396 may comprise a generally elongate,cylindrical body 408 suitable for coupling to the catheter 384 and tothe wire spade 388 on opposite ends. As shown in FIG. 15B, a proximallumen 412 is centrally disposed within the catheter head 396 andconfigured to receive a distal end of the catheter 384, as shown inFIGS. 12A-13. A distal lumen 416 is in fluid communication with theproximal lumen 412 and is configured to allow passage of the curvedneedle 392 extending distally from the catheter 384. Two wire receivinglumens 420, 424 are distally disposed within the catheter head 396 onopposite sides of the distal lumen 416. It will be appreciated that thetwo wire receiving lumens 420, 424 are configured to receive the ends ofthe wire spade 388 such that the wire spade has a desirable orientationfor stabilizing the spade-shaped assembly, e.g., as shown in FIGS.12A-13. The wires spade 388 may be secured within the lumens 420, 424 inany suitable manner, e.g., by adhesion, bonding, welding, mechanicalconnection, etc. As best shown in FIG. 15C, at least a portion of thedistal lumen 416 may comprise a raised or angled wall 428. As will beappreciated, the raised or angled wall 428 may serve to direct and/orallow the curved needle 392 to move in a desired direction relative tothe wire spade 388 and/or the catheter 384.

FIGS. 16-17 illustrate exemplary embodiments of a flexible needle 432,which may be utilized in a capacity the same as or substantially similarto that of the needle 392 and/or the inner needle 400, described inconnection with FIGS. 12A-15C. The flexible needle 432 may be includedin the anchoring systems or systems for setting an anchor describedherein. The flexible needle 432 may generally comprise a hollow, shapememory tube 436 having a multiplicity of slits 440 disposed along thefull length of the needle or along a portion of the needle (e.g., adistal portion of the needle). The shape memory tube 436 may beconstructed of nitinol, a shape memory alloy, or another suitablematerial. The slits 440 may be of a variety of shapes/configurations,e.g., S-shaped slits, C-shaped slits, V-shaped slits, zig zag slits,straight slits, curved slits, parallel slits, diagonal slits, etc. FIG.17 is a close-up view of an exemplary flexible needle 432 showing slits440 as S-shaped slits along a distal portion of the needle. The slitsmay be along different portions of the tube, e.g., FIG. 16 shows theslits 440 on the same side as the point of the beveled or sharpened tipof the needle, whereas FIG. 17 shows the slits 440 on the side of theneedle opposite the point of the beveled or sharpened tip of the needle.In one embodiment, slits 440 may appear alternating on opposite sides ofthe needle or appear at varying locations around the needle (e.g.,spaced apart in a helical shape around the needle) so the needle canmore readily flex in more than one direction. The slits 440 allow theflexible needle 432 to undergo sharp turns when delivered inside acatheter 444 as shown in FIG. 16 (or optionally, when delivered inside acurved needle 392), but allow the flexible needle 432 to resume astraightened configuration when extracted or pushed from the catheter444 (or curved needle 392), as shown in FIG. 17. The flexible needle 432may be capable of turns from 1 degree to greater than 90 degrees havinga relatively small radius. Further, the slits 440 (e.g., S-shaped slits)may provide a degree of rigidity to the flexible needle 432 in thestraightened configuration, including by allowing a surgeon to changethe orientation of the tip of the needle 432 by rotating a proximal endof the needle extending from the catheter 384. S-shaped slits may beless likely to break when rotated from a proximal end of the needle thanstraight slits. The flexible needle 432 is well suited to navigatethrough tortuous paths, and may enable the surgeon to puncture tissue ina direction different from a previous penetration direction. Thecatheter 444 may be a directional catheter that can be transitioned froma straight configuration to a curved, bent, and/or angled configuration.The catheter 444 may be flexible, rigid, or semi-rigid.

In some embodiments the flexible needle 432 may be used to deliverdevices by way of the hollow tube 436, such as guidewires or smalldiameter catheters or needles. In some embodiments, the hollow tube 436may be used to measure pressure where the distal tip of the needle islocated. In some embodiments the flexible needle 432 may be utilized asa guidewire during interventions lacking direct visibility. For example,the flexible needle 432 may be used during percutaneous cardiology orradiology interventions, using ultrasonic, angiogram, and/or fluoroscopyimaging modalities, such as during transcatheter left ventricleremodeling procedures for treating left ventricle dilation and anyassociated functional mitral regurgitation, e.g., as described herein.During transcatheter left ventricle remodeling, for example, theflexible needle 432 may be delivered through the catheter 444 orcatheter 384 to the right ventricle 120 of the heart 108 and thenoriented toward the septum 132 with a desired orientation. Uponpenetrating the septum 132 and entering the left ventricle 116, theflexible needle 432 may resume the straightened configurationillustrated in FIG. 17. In the straightened configuration, the flexibleneedle 432 may be oriented toward a desired puncture site on theposterior wall of the left ventricle 116. In those instances wherein anadditional orientation is required, however, the surgeon may manipulateor rotate the proximal end of the flexible needle 432 so as to orientthe flexible needle toward the desired puncture site. Optionally,flexible needle 432 may be delivered through an assembly similar tospade-shaped assembly 380 in the way described above with respect tospade-shaped assembly 380, e.g., flexible needle 432 may be delivered asthe curved needle 392 or the inner needle 400 while the spade-shapedassembly 380 is stabilized in the right ventricle.

FIGS. 18A-18C illustrate an exemplary embodiment of a trocar catheter448 configured for puncturing tissue. The trocar catheter 448 may bepart of an anchoring system or system for setting an anchor as describedherein. The trocar catheter 448 may generally comprise an elongatecannula 452 having a distal end 456 and a proximal handle 460. As willbe appreciated, the cannula 452 may comprise a hollow interior lumen 450which may contain a trocar 464. The trocar 464 may comprise a trocarshaft and a trocar distal tip 468. The trocar shaft may be rigid,semi-rigid, or flexible (e.g., to make navigation to the desiredlocation easier) and may have a lumen therethrough. The trocar 464 ortrocar shaft may extend from the proximal handle 460 to a trocar distaltip 468. The proximal handle 460 facilitates a surgeon advancing thetrocar distal tip 468 beyond the distal end 456, as shown in FIG. 18B,during puncturing of tissue. The handle may include controls (e.g., alever, button, switch, sliding mechanism, plunger, etc.) for causing thedistal tip 468 of the trocar to extend from the distal end of thecannula 452 for puncturing tissue and/or for causing the distal tip 468to retract into the lumen of the cannula 452 to prevent damage to tissuefrom the trocar. FIG. 19B is a close-up view of the trocar distal tip468 extending beyond the distal end 456, as shown in FIG. 18B, inaccordance with the present disclosure.

FIG. 18D is a cross-sectional view, taken along a midline of theproximal handle 460, that illustrates controls, e.g., including aplunger mechanism 472, that enable the surgeon to deploy the trocardistal tip 468 during puncturing of tissue and then withdraw or retractthe trocar distal tip into the distal end 456, as shown in FIG. 18C.FIG. 19C corresponds to the region in the dotted circle shown in FIG.18C and is a close-up view of the trocar distal tip 468 positionedwithin the interior lumen 450, proximal of the distal end 456. As willbe appreciated, withdrawing the trocar distal tip 468 into the lumen 450in the distal end 456 of the cannula 452 prevents unwanted damage tosurrounding tissues during delivery of the trocar catheter 448.

As illustrated in FIGS. 18A-18D, the trocar catheter may comprise anactuator 476 configured to deploy the trocar distal tip 468, as shown inFIG. 18B. The actuator 476 may be part of or work with the plungermechanism 472. The plunger mechanism 472 may comprise a spring 480 thatbiases the trocar distal tip into the retracted position, i.e., theposition in which the distal tip 468 is retracted into the lumen 450 inthe distal end 456. If a spring 480 is used, the distal tip 468 mayautomatically retract into the lumen 450 or into the distal end 456 whenthe surgeon releases the actuator 476. The actuator 476 may connect(directly or indirectly) to a proximal end of the trocar 464 and may bepushed toward the distal end 456 of the cannula 452 to cause the distaltip 468 of the trocar to extend out from the lumen 450. In FIG. 18D, thedistal end of the actuator 476 is shown as aligned with anothercomponent or plunger 474 having a ridge or lip on an outer surfacethereof that contacts the proximal end of the spring 480. The componentor plunger 474 having the ridge or lip may also include a lumen throughwhich a shaft of the trocar 464 may pass. In one embodiment, the distalend of the actuator 476 may push against the component having the ridgeor lip and may thereby compress the spring 480 to allow the distal tip468 of the trocar 464 to move distally and extend out from the lumen 450and distal end 456 of the cannula. When the actuator 476 is released,spring 480 may then cause the component having the ridge or lip to moveproximally and thereby push the actuator proximally to cause the distaltip 468 to move proximally into the lumen 450 and distal end 456. Othercontrols for moving the trocar between the extended and retractedpositions are also possible. A lock may be used to hold the trocar ineither the extended or retracted position.

FIG. 19A is a perspective view of the trocar distal tip 468 inaccordance with the present disclosure. The trocar distal tip 468 maycomprise one or more surfaces 484 to form a sharpened or a puncture tip,e.g., the distal tip 468 may have one, two, three, four, five, six, ormore surfaces 484. The surfaces 484 may be formed/manufactured bygrinding or milling the surfaces 484, e.g., the surfaces 484 may eachcorrespond to a grinding plane and be planar surfaces. In FIGS. 19A-19C,the distal tip 468 is shown as having been ground or milled to formthree grinding plane surfaces 484 that meet to form a sharp tip. Theactuator 476 may be rotatable so as to enable the surgeon to turn thesurfaces 484 of the trocar distal tip 468 during tissue puncturing.Further, the trocar distal tip 468 may comprise a lumen 492 in fluidcommunication with one or more ports 496 disposed on one or more or allof the surfaces 484. The lumen 492 and ports 496 may be configured forcontrast injection therethrough before, during, and/or after tissuepuncturing.

FIGS. 20A-20C illustrate an exemplary embodiment of an introducersystem/assembly 500 suitable for interventional cardiology procedures.The introducer system/assembly 500 may be included as part of theanchoring systems or systems for setting an anchor described herein. Theintroducer system/assembly 500 may comprise a needle or needle catheter504 and an introducer 508 disposed within an inner lumen of the needlecatheter 504. The needle catheter 504 may comprise a beveled edge 512 orother sharpened edge/tip suitable for puncturing tissue. As shown inFIG. 20A, the introducer 508 may be disposed within the needle catheter504 such that a portion of the introducer 508 extends distally beyondthe beveled edge 512. The distal portion of the introducer 508 maycomprise an atraumatic and/or blunt shape (e.g., rounded, partiallyrounded, flat, etc.) so as to operate as an atraumatic distal end of theintroducer system 500 during delivery of the needle catheter 504 to thesite of a puncture, as well as removal therefrom.

A spring or other biasing mechanism (not shown) may be included as partof the introducer system/assembly 500. The spring or other biasingmechanism maintains/biases the introducer 508 such that a distal portionof the introducer extends distally beyond the beveled edge 512, e.g., asshown in FIG. 20A. Upon applying pressure to the introducer 508, such asdue to pushing the needle catheter 504 distally against a tissue, theintroducer may be pushed/slid proximally into the needle catheter 504,thereby exposing the beveled edge 512 or other sharpened edge/tip asshown in FIG. 20B. Once exposed, the beveled edge 512 is suitable forpuncturing tissue, such as muscle tissue, so as to provide access to acavity or structure. e.g., in the heart. The introducer 508 returns tothe distally extended position shown in FIG. 20A upon entering into thecavity, thereby preventing the beveled edge 512 from damaging sensitivestructures within the cavity or nearby tissues. It is contemplated thatin some embodiments, springs exhibiting different degrees of springforce may be incorporated into the introducer system/assembly 500, andthus the springs may be selected according to a known level of forcerequired to penetrate a particular tissue (e.g., to prevent tissuepuncture in some tissues, but allow tissue puncture in other hardertissue). Further, in some embodiments, the introducer system/assembly500 may include a lock or locking feature that allows the introducer 508be locked into the distally extended position so as to enable pushingagainst tissue without the beveled edge 512 puncturing the tissue, e.g.,by preventing the introducer 508 from moving proximally in the needlecatheter.

The introducer system/assembly 500 may also include a guidewire 516. Theintroducer 508 may comprise an inner lumen which accommodates aguidewire 516. As shown in FIG. 20C, the inner lumen in the introducer508 facilitates advancing the guidewire 516 without requiring theintroducer 508 to be withdrawn from the needle catheter 504. Thus, theinner lumen enables the guidewire 516 to be advanced while theintroducer 508 protects adjacent tissues from damage from the bevelededge 512. Further, the inner lumen enables the needle catheter 504 andthe introducer 508 to be retracted together from the tissue or cavitywhile the guidewire 516 is left remaining in the deployed position. Aswill be appreciated, delivery of the guidewire 516 through the innerlumen of the introducer 508 substantially eliminates injury to nearbystructures and tissue that might otherwise occur due to the presence ofthe beveled edge 512 in absence of the introducer. Further, having alumen through the introducer 508 saves time and the extra step of havingto retract the introducer 508 or a similar component from the needlecatheter prior to advancement of a guidewire or other instrumentstherethrough.

FIGS. 21A-21C illustrate an exemplary embodiment of a threadedintroducer 520 suitable for use during medical treatment. The threadedintroducer 520 may be particularly effective when used in moving tissue,e.g., in a beating heart. The threaded introducer 520 may be included aspart of an anchoring system or system for setting an anchor. Thethreaded introducer 520 may be used in treating heart dilation (e.g.,left ventricle dilation) and functional mitral valve regurgitation (FMR)as described herein. The threaded introducer 520 comprises a generallyelongate shaft 524 having a proximal head 528 and a distal end 532. Theproximal head 528 and/or the distal end 532 may include smooth,atraumatic surfaces so as to prevent damage to tissues and structuresduring delivery of the threaded introducer 520. A central lumen 536 mayextend the full length of the threaded introducer 520 from the proximalhead 528 to the distal end 532. As can be seen in FIG. 21C, the proximalhead 528 and the portion of the central lumen 536 therein may beconfigured to fixedly receive a distal end of a catheter or otherinstrument. The threaded introducer 520 and the central lumen 536 may beconfigured for contrast injection therethrough to facilitate observationof the position of the threaded introducer 520, surrounding, tissues,and/or other instruments during treatment of a patient. The threadedintroducer 520 may be configured for power injection of contrast fluidas well, e.g., the threaded introducer and/or its lumen may bereinforced or structured to withstand high pressures typical of powerinjection. Further, the distal end 532 comprises a distal tip openingand one or more than one lateral port 540 in fluid communication withthe central lumen 536. As will be appreciated, the lateral port 540operates to further enhance contrast injection along the sides of thethreaded introducer 520. Contrast injection by way of the lateral port540 and the central lumen 536 may provide improved imaging of surroundtissue and/or accurate location and depth information during advancingthe threaded introducer 520 within the heart 108.

The elongate shaft 524 may comprise one or more threads 544 disposedalong the length of the threaded introducer 520. The threads 544facilitate rotatably engaging the threaded introducer 520 within atissue, such as by way of non-limiting example, the myocardium of theheart 108. During operation of the threaded introducer 520, rotating thecatheter shaft, whether flexible or rigid, causes the threadedintroducer 520 to turn whereby the threads 544 become engaged with themyocardium. As the threaded introducer 520 continues turning, thethreads 544 draw the threaded introducer deeper into the myocardium,effectively “screwing” the threaded introducer 520 into the myocardium.It will be appreciated, that the threads 544 advantageously eliminate aneed for a pushing force that is typically required to puncture themyocardium by way of a needle or trocar. Further, the threadedintroducer 520 is particularly advantageous for delivering a catheterinto a moving tissue, such as by way of non-limiting example, a beatingheart 108. As will be recognized, depth control and locationidentification often are nearly impossible to observe and control whenpushing a needle, catheter, trocar, or other puncturing instrument intoa beating heart. The threads 544, however, prevent the tissue frommoving relative to the threaded introducer 520 until the surgeon furtherrotates the catheter shaft. Thus, the threaded introducer 520 providesvery accurate depth control during delivery into the beating heart, aswell as providing an essentially self-advancing catheter. This also helpprevent damage to external or surrounding tissues that might otherwisebe damaged as the tissue moves and the physician attempts to puncturethe moving tissue.

As stated above, the threaded introducer 520 is particularly well-suitedfor use during treatment of FMR, wherein it is desirable to cross theseptum 132 and the myocardium with a medium size catheter, such as a 10French-sized catheter. For example, after passing through the septum132, the threaded introducer 520 may be advanced across the leftventricle 116 to the posterior wall. A needle may be advanced throughthe central lumen 536 so as to create a surface puncture in theposterior wall to receive the distal end 532. Once the distal end 532enters the puncture, carefully rotating the catheter shaft screws thethreaded introducer 520 into the posterior wall without crossing all theway through the myocardium. Contrast injection may be performed by wayof the central lumen 536 and the lateral port so as to help image thearea and judge the depth and location of the threaded introducer 520and/or to view the surrounding tissue and/or other instruments used. Inone embodiment, an ultrasound/echo probe may also or alternatively beused. Upon further rotating the catheter shaft, the surgeon may slowlyadvance the threaded introducer 520 and the catheter through themyocardium into the pericardial cavity without piercing the pericardium.It should be recognized that the smooth surfaces of the threadedintroducer 520 and the threads 544 may provide a controlled crossing ofthe myocardium without damaging the pericardium, the coronary arteries,or other surrounding tissue.

As will be appreciated, some treatments may require passing the catheterbeyond the pericardial cavity, and thus call for puncturing thepericardium. Once in the pericardial cavity, the threaded introducer 520may be advanced to a desired puncture site on the pericardium. A needlemay be delivered through the central lumen 536 so as to carefully createa puncture in the pericardium to receive the distal end 536. Thecatheter shaft may be rotated to engage the threads 544 with thepericardium and then advance the threaded introducer 520 and thecatheter shaft through the pericardium. The smooth surfaces of thedistal end 532 and the proximal head 528 ensure that the threadedintroducer 520 advances beyond the pericardium without damaging thelungs or other nearby organs and tissues of the patient.

FIGS. 22A-22C illustrate an exemplary embodiment of a cutting catheteror cutter catheter 600 (e.g., a suture cutter catheter) suitable for useduring medical treatment. The cutter catheter 600 may be included aspart of an anchoring system or system for setting an anchor as describedherein. The cutter catheter 600 may be used in various treatments,including treating dilation and functional mitral valve regurgitation(FMR) as described herein. For example, the cutter catheter 600 may be asuture cutter catheter used to cut sutures that are implanted to sealand/or repair punctures, holes, cuts, or other tissue damage from themedical treatment (e.g., from the FMR treatment). The cutter catheter600 may comprise one or more of the following: an outer tube 602, aninflation tube 604, a positioning tube 606, a balloon 608, a cut blade610, a moving plate 614, a spring 616, and/or other components. Theouter tube 602 may be formed of a rigid or semi-rigid material and maycontain one or more of the other components of the cutter catheter 600.In one embodiment, the outer tube 602 may contain the entire cuttingmechanism of the cutter catheter 600. FIG. 22B shows an interior view ofthe suture cutter catheter 600 and reveals exemplary components of acutting mechanism contained in the outer tube 602. FIG. 22C shows across sectional view of the cutter catheter 600 taken along the dottedline labeled 22C in FIG. 22B.

The cutter catheter 600 may be assembled inside of a long, flexiblecatheter shaft. In one embodiment, the outer tube 602 is a long,flexible catheter shaft or a portion of a long, flexible catheter shaft.In one embodiment the outer tube 602 is arranged inside a portion of aseparate long, flexible catheter shaft, e.g., in a distal end of thelong, flexible catheter shaft. The outer tube 602 may be fixedlyattached inside a long, flexible catheter shaft, or may be delivered ina long, flexible delivery catheter to the cutting location. Advantagesof the cutter catheter 600 include, without limitation, (1) “unlimited”length, i.e., any length may be used (e.g., the cutter catheter 600 caneffectively cut a suture at the end of a very long catheter or tube along distance into a body), (2) “unlimited” flexibility, i.e., thecatheter may have any range of flexibility (e.g., the cutter catheter600 or a portion thereof can itself be very flexible or the cuttercatheter 600 can be delivered/advanced inside a separate, but veryflexible catheter, such that the cutter catheter 600 may be navigatedthrough a tortuous path in the body and used a long distance into thebody of a patient, and (3) application of a high, controlled force(e.g., the mechanism allows for a high, controlled cutting force even ata remote location a long distance in the body or a long distance fromthe proximal end of the catheter).

The suture cutter catheter 600 may include a balloon 608 that may beinflatable by a fluid, e.g., by air, water, saline solution, etc. Theballoon may be located between a first side of the inner wall of theouter tube 602 and a moving plate 614. Inflation tube 604 may include alumen in fluid communication with the balloon 608. The inflation tube604 may be configured for connection to an elongate tube or catheterconnected to a fluid source and/or for connection directly to a fluidsource. Fluid may flow from the fluid source to the inflation tube 604and into the balloon 608 to inflate the balloon 608. In one embodiment,the fluid source is high pressure syringe, e.g., as used to inflatecoronary balloons. When inflated, the balloon 608 may expand and therebycause the moving plate 614 to move toward the cut blade 610, which maybe located on a second side of the inner wall of the tube, e.g.,opposite the balloon 608. The moving plate 614 may be a rigid orsemi-rigid plate capable of firmly pressing a suture 620 or othermaterial against the cut blade 610 to cut the suture 620 or othermaterial. The blade 610 may be a sharp blade having a sharp edge 612configured for easily and cleanly cutting a suture 620 or othermaterial. The moving plate 614 may move toward the blade 610 until themoving plate 614 directly contacts the sharp edge 612 of the cut blade610, thereby cutting/severing any suture or other material between themoving plate 614 and the blade 610. The moving or pressing force thatmoves the moving plate 614 toward the blade 610 may be generated byinflating the balloon 608, e.g., by hydraulic action.

The suture cutter catheter 600 may also include a biasing component,mechanism, or spring 616 that biases the moving plate 614 away from theblade 610. The biasing component, mechanism, or spring 616 may connectbetween the moving plate 614 and the first side of the inner wall of theouter tube 602 opposite the blade 610, e.g., the spring 616 may connectdirectly to the moving plate 614 and to the first side of the inner wallof the outer tube 602. When the balloon 608 is inflated the moving plate614 moves away from the first side of the inner wall toward the cutblade 610 thereby expanding/tensioning the biasing component, mechanism,or spring 616. The biasing component, mechanism, or spring 616 biasesthe moving plate 614 to move toward the first side of the inner wallaway from the cut blade 610, so that after the pressing force is nolonger supplied by the balloon 608 (e.g., when the balloon deflates orimparts less pressure), the moving plate 614 automatically moves awayfrom the blade 610 or toward the first side of the inner wall of theouter tube 602.

The suture cutter catheter 600 may also include a positioning tube 606.Positioning tube 606 may be a polymer or plastic tube. Optionally, thepositioning tube 606 may be constructed of a material that may bereadily cut by the blade 610, and/or the positioning tube 606 mayinclude a break or separation in the tube 606 in the region where thecut blade 610 contacts the moving plate 614 to ensure the positioningtube 606 does not interfere with cutting the suture 620 or othermaterial. The positioning tube 606 may include a lumen 618 in which asuture 620 or other material to be cut may be received. The positioningtube 606 may be adhered, bonded, glued, or otherwise affixed to themoving plate 614 to ensure that a suture 620 or other material in thelumen 618 of the positioning tube may be properly positioned/located forcutting, e.g., to ensure a suture 620 or other material is in the properlocation between the blade 610 and the moving plate 614 during cutting.The suture 620 or other material may be threaded through the positioningtube 606 before cutting to properly position the suture 620 or othermaterial. For example, a free end of a suture may be threaded through adistal end of the positioning tube 606 and through the lumen 618. Thepositioning tube 606 may then be advanced along the suture to a pointwhere the cut is desired. When properly positioned as desired, theballoon 608 may be inflated thereby pressing the moving plate 614 to thecut blade 610 until the suture 620 or other material is cut/severed bythe cut blade 610. The suture cutter catheter 600 can make it easier toeffectively cut thick, strong, or otherwise difficult to cut sutures,lines, members, etc. For example, the suture cutter catheter 600 iseffective at cutting sutures, lines, members, etc. made from very strongfibers, like Dyneema fibers or strong Ultra High Molecular WeightPolyethylene (UHMWPE) fibers. The suture cutter catheter 600 could alsobe used to cut any excess unused portion of a tension member.

FIGS. 23A-23C illustrate an exemplary embodiment of a device 700suitable for use during medical treatment and the methods describedherein and which may be part of one or more of the systems describedherein. The device/catheter 700 may be formed as a C-shaped device orcatheter. The device/catheter 700 may be a puncture location device orpuncture location catheter, and may be a multipurpose device that helpsidentify a puncture location, facilitates deployment of one or moreanchors, and/or performs other functions. The device/catheter 700 may beincluded as a part of an anchoring system, as described herein. Thedevice/catheter 700 may be used in a variety of treatments, includingtreating dilation and functional mitral valve regurgitation (FMR), asdescribed herein. For example, the device/catheter 700 may be used aspuncture location device/catheter to identify a desired puncturelocation and/or guide puncturing devices to create a puncture in thedesired puncture location, e.g., a desired puncture location on a wallof an organ. For example, device/catheter 700 may be used to identify apuncture location and guide a puncturing device to location on a wall ofa left ventricle of a heart and/or a posterior wall of the heart 108that avoids or minimizes damage to the papillary muscles 144 or othervessels, tissue, etc., during medical treatment.

The device/catheter 700 may include a proximal handle 702, a positioningtube 704, and/or other features. Proximal handle 702 may facilitategripping and moving the device/catheter 700. Proximal handle 702 mayfacilitate navigating the device/catheter 700 through an incision siteand to a desired location. This may include navigating thedevice/catheter 700 around a portion of the heart or another organ, to adesired location/position. For example, proximal handle 702 may be usedto direct/navigate the distal end of the device/catheter 700 around theregion of a heart including the left ventricle 116 so as to position adistal end/region of the device/catheter 700 at a desired location alonga wall of the heart (e.g., at a desired puncture location for puncturethrough the heart wall or a wall of the left ventricle). Thedevice/catheter 700 may be used to help locate/identify a locationoutside a posterior side of the human heart 108 (e.g., a location alongthe posterior wall of the left ventricle at which puncturing would avoidor limit damage to blood vessels, papillary muscles, etc.). Pressing aportion of the device/catheter 700 (e.g., a guide portion 724 and/or afinger 706) into and/or moving the portion along a wall (e.g., posteriorwall) of the human heart 108 (or another organ or portion of the body)may cause a bend or bulge in the wall of the heart (or other organ orportion of the body) that is detectable/viewable by way of an epicardialecho probe or ultrasound probe or another imaging device. Thedevice/catheter 700 may thereby enable a surgeon to identify a locationon an organ, heart, or portion of the body that is suitable for beingpunctured during medical treatment (e.g., during FMR treatment) withoutcausing undue damage (e.g., avoiding undesired damage to vessels,papillary muscles, and/or tissue structures within the left ventricle116 of a heart).

In the embodiment illustrated in FIGS. 23A-23C, the device/catheter 700includes a positioning tube 704. Positioning tube 704 can be formed andconfigured as a generally long, thin tube having a shape suitable forbeing directed into an incision site and navigated around a portion of aheart or other organ to a desired location, e.g., around the exterior ofa left ventricle 116 to the posterior side of the left ventricle 116 ofa heart 108. The positioning tube 704 may be comprised of an elongateportion 708 and a curved portion 712 that may be connected together (orconnectable together). For example, elongate portion 708 and a curvedportion 712 may be connected or be connectable by way of a proximal bend716. In one embodiment, the positioning tube 704 may be comprised of asingle-piece, integral component that may be suitablymanipulated/shaped/molded/etc. to form the curved portion 704 and theproximal bend 716. In one embodiment, the positioning tube 704 may becomprised of several separate tube segments that may be individuallymolded, manipulated, or fabricated and then adhered, bonded, glued, orotherwise assembled to form the shape of the positioning tube 704illustrated in FIGS. 23A-23B.

The curved portion 712 may comprise a radius of curvature suitable forextending around the left side of the human heart 108 or for extendingaround another organ or portion of a body. An elbow portion 720 and aguide portion 724 may be included at a distal end/region of thepositioning tube 704. The elbow 720 may be disposed at a distal end ofthe curved portion 712. The guide portion 724 may be disposed at adistal end of the elbow 720 or an end opposite the curved portion 712.The elbow 720 and/or the guide 724 may be adhered, bonded, glued, orotherwise affixed to the distal end of the curved portion 712. Though,in one embodiment, an elbow portion the same as or similar to elbow 720and/or a guide portion the same as or similar to guide portion 724 couldbe made/formed integral with other portions as part of a single-piecepositioning tube or device/catheter. In one embodiment, the elbow 720imparts a 90-degree bend to the distal end of the curved portion 712,such that the guide 724 is oriented toward, and aligned with, alongitudinal axis 728 of the elongate portion 708, as shown for examplein FIG. 23B.

Guide portion 724 may be formed in a variety of sizes and shapes. In oneembodiment, the guide portion 714 may be columnar or generally columnarin shape. A front region of guide 724 (e.g., opposite the elbow 720and/or facing toward the elongate portion 708) may be pressed or pulledagainst a portion of an organ or part of the body (e.g., a heart) andmay cause a bending or bulging in the wall that may be visible with anecho probe or ultrasound probe or other imaging equipment. Doing thismay help a user to identify and mark a desired puncture or treatmentlocation on the organ or part of the body (e.g., on a wall of a heart).Guide portion 724 may include a concave or inwardly tapered front region(e.g., on the end opposite elbow portion 720). This front region may becurved into a concave or generally concave region or may be taperedinwardly to form a conical or generally conical region within the frontend of the guide 724. This concave or inwardly tapered front region mayhelp receive a puncturing device through the organ or part of the body,e.g., the concave or inwardly tapered front region may help guide andreceive a needle or other puncture device passing through a wall of theheart. If the device/catheter 700 has only a single lumen (though someembodiments may have more) and no finger 706, applicator 732, or deviceconnecting these are used (i.e., if these do not block the lumen of thedevice), then the lumen may be used to help deploy and/or use an anchoror other medical device to the puncture/treatment location. For example,a tension member of an anchor may be passed through the lumen and may besnared by the puncturing device or another device that passes throughthe puncture, then the puncturing device or snare may be withdrawnthrough the puncture bringing the tension member with it and leaving theanchor deployed outside the puncture.

The device/catheter 700 may also include a finger 706, which may becoupled with guide portion 724 and/or may reside partially or fullywithin guide portion 724. Finger 706 may be configured in a variety ofshapes and sizes, e.g., columnar, conical, rounded, flat, curved, andmany more. Finger 706 may be thick or thin and may be solid or hollow.In one embodiment, the finger 706 may be oriented toward, and alignedwith, a longitudinal axis 728 of the elongate portion 708, as shown inFIG. 23B. The alignment of the finger 706 with the longitudinal axis 728of the elongate portion 708 may help enable the surgeon touse/manipulate the proximal handle 702 such that the device/catheter 700may be used to determine a location and orientation of the guide 724and/or finger 706 (e.g., when located near an organ or, for example,near the posterior side of the human heart 108).

A front region of finger 706 (e.g., facing away from the elbow 720and/or facing toward the elongate portion 708) may be pressed or movedagainst a portion of an organ or part of the body (e.g., a heart) toidentify and mark the desired puncture or treatment location on theorgan or part of the body (e.g., on a wall of a heart). The finger 706may be slidably coupled with the guide 724. The finger 706 may beconfigured and designed to be movable and/or may be configured anddesigned to be transitionable between two or more configurations.Transitioning between the configurations or moving the finger may helpthe user to identify the location of the finger 706 when viewing theorgan or portion of the body (e.g., heart) with an echo probe orultrasound probe or other imaging equipment, e.g., movement ortransitioning of the finger may cause portions of an organ or heart tobend, bulge, or move in a way that can be seen with imaging equipment.If used to identify a desired puncture location on a heart, pressing thefinger 706 into and/or moving the finger 706 along the side or wall ofthe heart may cause a slight bend or bulge in the wall of the heart thatmay be detectable/viewable by way of an epicardial echo probe orultrasound probe or other imaging equipment. The finger 706 may therebyaid a surgeon in identifying a location on the wall that is suitable forbeing punctured (e.g., during FMR treatment) without causing damage tovessels, papillary muscles, and/or tissue structures within the leftventricle 116.

Finger 706 may be configured to retract entirely within the guide 724 orto have a portion of the finger 706 that remains outside the guide 724.In one embodiment, finger 706 may be a wire, a wire-like device, or maybe another long, narrow device that can extend from the guide 724 orretract within the guide 724. In one embodiment, finger 706 may becolumnar or generally columnar and may act similar to a column or buttonthat pushes out from the guide 724 to contact and press against an organor part of the body. In one embodiment the finger 706 may have adiameter similar to or slightly less than the guide 724. The finger 706may slide within the guide 724 to extend out from or retract within theguide 724 and thereby transition between an extended configuration and aretracted configuration. In one embodiment, the finger 706 may include aportion with a larger diameter or width that remains outside the guide724 (e.g., between the guide 724 and elongate portion 708) and a portionwith a smaller diameter or width that slides within and partiallyoutside the guide 724 to transition the finger 706 between an extendedconfiguration and retracted configuration. A larger diameter region of afinger 706 may be conical or generally conical in shape (e.g., may havea region with a continuous transition from a larger diameter to asmaller diameter).

Finger 706 and/or guide 724 may include a concave or inwardly taperedfront region (e.g., on the end facing away from elbow portion 720 andtoward elongate portion 708). This front region may be curved into aconcave or generally concave region or may be tapered inwardly to form aconical or generally conical region within the front end of the finger706 or guide 724. This concave or inwardly tapered front region may helpreceive a puncturing device through the organ or part of the body, e.g.,the concave or inwardly tapered front region may help guide and receivea needle or other puncture device passing through a wall of the heart.

The finger 706 may be moved and/or transitioned between configurations(e.g., extended and retracted) by way of a long, flexible cathetershaft, wire, tube, pusher, etc. that extends from the finger 706 to anapplicator 732, which applicator 732 may be disposed near the proximalend of the catheter/device 700 or near handle 702. The catheter shaft,wire, tube, pusher, etc. may be routed from the finger 706, within alumen of the curved portion 712, and to the applicator 732. An actuatortube 736 may act as the flexible catheter shaft, wire, tube, pusher,etc. that extends through the curved portion 712 to the finger 706 tocause the finger 706 to move or transition between configurations, orthe actuator tube 736 maybe provide a connecting lumen through which theflexible catheter shaft, wire, tube, pusher, etc. passes from theapplicator 732 to the curved portion 712. The actuator tube 736 may beslidable within or otherwise connected, adhered, bonded, glued, oraffixed to the curved portion 712 to ensure that the finger 706 moves asdirected by movement of the applicator 732 (e.g., a user should be ableto move the applicator 732 to cause the finger to move or transitionbetween configurations).

The device/catheter 700 may further include a spring, or other biasingcomponent, that biases the finger 706 to a retracted configuration(e.g., biases the finger 706 toward or within the guide 724 and/or elbow720). In one embodiment, the spring may be coupled between theapplicator 732 and the actuator tube 736 and/or within the applicator732, such that when a pressing force is applied to the applicator 732,the spring is compressed and the flexible catheter shaft, wire, tube,pusher, etc. moves distally and pushes the finger 706 to an extendedconfiguration (e.g., such that the finger 706 can push against a wall ofa heart, organ, or other part of the body). In one embodiment, thespring may bias the applicator 732 or a portion of the applicator 732proximally away from the actuator tube 736, such that after the pressingforce is no longer applied to the applicator 732 the springautomatically moves the flexible catheter shaft proximally and pulls thefinger 706 toward and/or within the guide 724. It should be understoodthat the spring, or other biasing component, is not to be limited tobeing disposed between the applicator 732 and the actuator tube 736, butrather the spring, or other biasing component may be disposed in anylocation of the puncture location catheter 700 that is suitable forbiasing the finger 706 toward the guide 724, as described herein. Forexample, in one embodiment, the spring or biasing component may bedisposed within the guide 724.

In one embodiment, e.g., as shown in FIGS. 23A-23C, the long, thinpositioning tube 704 may comprise at least one interior lumen that isdedicated to routing the flexible catheter shaft, wire, tube, pusher,etc. from the applicator 732 to the finger 706, as described above. Inone embodiment, the positioning tube 704 may comprise more than oneinterior lumen, e.g., two, three, or four interior lumens, withoutlimitation. In one exemplary embodiment, the positioning tube 704 maycomprise at least (1) a first lumen that may be used to direct theflexible catheter shaft, wire, tube, pusher, etc. to the finger 706, asdescribed herein, and (2) a second lumen that may be used to help deployan anchor (e.g., the superior anchor 136) or other medical device duringmedical treatment. For example, during FMR treatment, the finger 706through the first lumen may be used to help guide a needle catheter(e.g., a 4 or 5 French-sized needle catheter) or other puncturing deviceto puncture wall of the heart 108 (e.g., to puncture a wall of the leftventricle 116) in a desired puncture location, and the second lumen maybe used to deploy a tension member (e.g., tension member 128) and ananchor (e.g., superior anchor 136) to the puncture site. For example, atension member of an anchor may be passed through the second lumen andmay be snared by the puncturing device or another device that passesthrough the puncture, then the puncturing device or snare may bewithdrawn through the puncture bringing the tension member with it andleaving the anchor deployed outside the puncture. Similarly, if twolumens are not included within device/catheter 700, multiple separatesingle lumen devices could be used in a similar way, e.g., the lumen ofthe first device may help control a finger 706, and the lumen of asecond device may aid in deployment and/or use of an anchor or othermedical device.

In one embodiment, upon withdrawing the puncturing device/needle fromthe catheter, a snare may be inserted into the catheter and directedthrough the puncture in the organ (e.g., the puncture in a wall of theheart 108) to capture an end of the tension member 128 extended orpushed out of a lumen (e.g., a second lumen of device/catheter 700). Thesnare may then be used to draw the tension member 128 through the wallof the organ/heart and to pull the superior anchor 136 from the secondlumen into contact with the exterior of the posterior wall of the heart108. The tension member 128 extend across the left ventricle 116,through the wall of the septum 132 to an inferior anchor deployed at theseptum, or through the wall of the septum 132 and across the rightventricle 120 to an inferior anchor outside the right ventricle. Theinferior anchor may be mounted onto and/or connected to the end of thetension member 128 and may be positioned adjacent to the right ventricle120 (e.g., external to the heart outside the right ventricle as shown inFIGS. 1-2) or may be positioned inside the right ventricle against thewall of the septum 132. The inferior anchor 140 may be cinched orotherwise locked/attached onto the tension member 128 to impart anadvantageous shape change to the heart and/or annulus of the mitralvalve 112, as well as to advantageously reposition the papillary muscles144, as described herein.

Various methods of medical treatment, methods of treating dilation(e.g., left ventricle dilation) and/or mitral valve regurgitation,methods of implanting and/or securing a mitral valve splint, and othermethods are possible and contemplated using one or more of the systems,apparatuses, devices, steps, etc. described above. Also, various partsof the body (including, but not limited to, the heart) may be treatedusing one or more of the systems, apparatuses, devices, steps, etc.described above. For example, the various puncturing instruments/devicesdescribed may be used in many different applications to puncture a widevariety of tissue/body parts in various types of medical treatments.Steps described above and below with respect to the various methods,systems, apparatuses, assemblies, devices, etc. herein may be used invarious combinations.

Methods of medical treatment, methods of treating a heart condition,methods of implanting and securing a mitral valve splint, and/or othermethods may include any of the steps disclosed herein. For example,methods of treating a heart condition (e.g., left ventricle dilation,mitral valve regurgitation, etc.) may include accessing the heart or oneor more portions of the heart (e.g., accessing a right ventricle of theheart). Accessing the heart may be done by first making one or more thanone incisions to the body (e.g., the skin) to form one or more than oneaccess points. The access point(s) may be near the chest and/or heart ofa patient or may be remote from a patient's chest or heart (e.g., in anarm or leg or neck). Methods may include inserting an instrument intothe access point, moving the instrument to the heart, and entering aportion of the heart (e.g., entering the right ventricle). Entering theheart may be by way of an incision, puncture, hole, etc. in a portion ofthe heart, e.g., by an incision, puncture, hole, etc. in a wall of theright ventricle. Optionally, entering the heart may be done by firstentering a blood vessel, then advancing/inserting a medical instrument(e.g., a catheter or other instrument/device/apparatus/assemblydescribed herein) through the blood vessel and into a portion of theheart (e.g., the right ventricle).

Methods may include inserting/advancing a needle catheter (e.g., thesame as or similar to needle catheter 504) into the right ventricle ofthe heart, then through the septum between the right ventricle and theleft ventricle. A blunt tip introducer (e.g., the same as or similar tointroducer 508) may be inside the needle catheter and a blunt distal endof the introducer needle may be positioned near the posterior/left wallof the heart (i.e., the wall between the left ventricle and thepericardium). Methods may include passing a guide wire through aguidewire lumen in the introducer (e.g., introducer 508). Imagingtechniques can be used at various stages of treatment, including toguide the needle catheter to the correct puncture points and/or may beused to position a threaded introducer (e.g., the same as or similar tothreaded introducer 520) in the proper location in the posterior/leftwall of the heart. The imaging techniques can include introducing one ormore contrast solutions through the introducer and using an imagingsystem to view the contrast solution in the heart. The imagingtechniques can also include using an inserted echo or ultrasound probeto view portions of the treatment area (e.g., walls of the heart,puncture devices, an introducer, a finger/guide of a puncture locationdevice, etc.). In one embodiment, a threaded introducer (e.g., the sameas or similar to threaded introducer 520) may be advanced to theposterior/left wall of the left ventricle and may be rotated into theleft wall of the heart such that the rotation of the threads pulls thethreaded introducer into the wall in a controlled manner and anchors thethreaded introducer in the left wall. In one embodiment, anotherconduit, introducer, catheter, needle, puncturing device, etc. could beused to create an incision/puncture through the wall of the organ orheart. A guidewire may be advanced through the introducer, threadedintroducer, conduit, needle, and/or an incision/puncture in the wall ofthe heart (e.g., a posterior and/or left wall).

Methods may comprise advancing a distal end of the delivery catheterover the guidewire and through an introducer (e.g., the threadedintroducer), conduit, and/or incision/puncture into the pericardiumcavity or outside of the pericardium. The delivery catheter may beloaded with an anchor (e.g., the same as or similar to any of theanchors described above and/or shown in one or more of FIGS. 3A-11B).The anchor or a ring/wire of the anchor may be constructed of a shapememory material. The shape memory material ring/wire may be essentiallycollapsed, linear, and/or straightened in the delivery catheter, but mayautomatically become ring shaped (or assume a shape of one of the otheranchors described above) when moved out of the lumen of the deliverycatheter. The anchor may include a cover and/or a strip/strips of amaterial (e.g., PET, PTFE, etc.) that have a first end through which theshape memory material is threaded and a second end through which atension member or pull cord (e.g., the same as or similar to the tensionmembers described above) is threaded. When the anchor is deployed fromthe catheter and regains its ring shape, the tension member or pull cordmay be pulled such that the inner area of the ring is filled with thematerial (e.g., PET, PTFE, etc.) such that the anchor resembles a discshape and the cover material is straightened or tensioned to a flattenedconfiguration (e.g., a substantially or roughly flattenedconfiguration), and/or the tension member may pull the cover or aportion of the cover into a cone-like shape (e.g., as the tension memberis pulled away from the anchor). In one embodiment, the anchor may be amanually expandable anchor, e.g., similar to the manually expandableanchors discussed above, and may be expanded or deployed as discussedabove. Methods may also include deploying a second anchor on the rightor front side of the heart or pericardium (e.g., outside the rightventricle) or may include deploying the second anchor inside the rightventricle against a portion of the septum or septal wall. Methods mayalso include cinching the first and second anchors toward each other soas to contract the size/shape of the heart (or a portion of the heart)and ensure that the leaflets of the mitral valve properly overlap witheach other to prevent mitral valve regurgitation.

The methods disclosed herein may also comprise using an echo orultrasound probe (e.g., a trans-vaginal ultrasound probe or anultrasound probe designed for use in treatment of dilation, mitral valveincompetency, mitral valve regurgitation, and other similar conditions)to assist during treatment of conditions of the human heart. Theecho/ultrasound probe may have a guide attached thereto, the guide maybe configured for or be capable of guiding the delivery catheter to adesired location in the body or heart. The echo/ultrasound probe andguide may be part of an anchoring system or system for setting an anchordescribed herein. The methods and/or steps described elsewhere hereinmay be performed in conjunction with using the echo/ultrasound probe,e.g., to identify treatment sites/locations, to navigate the medicalinstruments/devices to a desired treatment site/location, and/or viewthe medical instruments/devices as they are used in a remote location inthe body.

The methods may comprise loading a medical instrument (e.g., a trocar,trocar catheter, needle, needle catheter, catheter, one of theinstruments/devices described herein, etc.) into a guide of theultrasound probe. The guide may be fastened to an ultrasound probecomprising an elongate shaft extending from a proximal handle to adistal end. The ultrasound probe may be inserted into a patient by wayof an incision. The distal end of the ultrasound probe may then benavigated to a location adjacent to an exterior surface of the heartand/or pericardium. A treatment site may be identified on an exteriorsurface of the heart and/or pericardium using an image(s) (e.g., alive/real-time image) obtained using an ultrasound transducer disposedwithin the distal end of the ultrasound probe. The medical instrumentmay be advanced within the guide to the treatment site, and thecondition of the heart may be treated. The medical instrument may alsobe withdrawn from the treatment site. In one embodiment, the methodinvolves using a trans-vaginal ultrasound probe for imaging in theheart. The trans-vaginal ultrasound probe can be used for navigationduring the methods and/or steps described herein and to position theintroducer correctly in the heart wall. The trans-vaginal ultrasoundprobe may be smaller than a typical epicardial echo probe. A guide maybe included on the trans-vaginal ultrasound probe to connect a punctureneedle or the needle catheter thereto to allow parallel insertion of theneedle catheter with the ultrasound probe.

In one embodiment, a method for medical treatment (e.g., for treatingdilation and mitral valve regurgitation) may comprise: inserting acatheter, a puncturing instrument (e.g., a trocar, trocar catheter,needle, needle catheter, curved needle, introducer, introducer assembly,a sharpened portion of an assembly, etc.) having a sharpened distal tip,guidewire, assembly, and/or other instrument into a right ventricle of aheart (e.g., a beating heart) of a patient. A guidewire may be insertedinto the right ventricle before other instruments, and then otherinstruments may be passed over the guidewire into the right ventricle.Inserting the catheter, puncturing instrument, guidewire assembly,and/or other instrument into the right ventricle of the heart may beaccomplished by passing the catheter, puncturing instrument, guidewire,assembly, and/or other instrument through an incision/puncture (e.g.,made using a scalpel, introducer, introducer sheath, needle, otherpuncturing instrument) in a wall of the right ventricle (e.g., a rightand/or anterior wall). Access to the wall of the heart may beaccomplished via an incision/puncture in the chest near the heart (e.g.,a small hole in the 4th inner costal, optionally, 5-7 mm in diameter).

Optionally, inserting the catheter, puncturing instrument, guidewire,assembly, and/or other instrument into the right ventricle of the heartmay be accomplished by first passing the catheter, puncturinginstrument, guidewire, assembly, and/or other instrument through anincision/puncture in a blood vessel at a point removed/apart from theheart and navigating the catheter, puncturing instrument, guidewire,assembly, and/or other instrument through the blood vessel and into theright ventricle. For example, this could be accomplished by passing thecatheter, puncturing instrument, guidewire, assembly, and/or otherinstrument into a subclavian, innominate vein, superior vena cave (SVC),or inferior vena cava (IVC), e.g., in the region of the neck, clavicle,or upper chest, and navigating the along the vessel through the rightatrium, through the tricuspid valve, and into the right ventricle.Incision/puncture locations at various points in the heart may beidentified in advance or during operation with imaging equipment.

An inserted catheter may be a directional catheter that is inserted intothe right ventricle as discussed above. The directional catheter may beable to transition between a straight or generally straightenedconfiguration to navigate to the right ventricle, then may betransitioned to an angled, bent, or curved configuration to help guideand direct an instrument (e.g., a puncturing instrument) passing throughthe directional catheter at the septum. This allows the puncturinginstrument to curve, bend, or angle toward the septum and puncture theseptum as desired, even when inserted from a region remote from theheart.

An inserted assembly may be a septum-puncture assembly that is insertedinto the right ventricle as discussed above. The septum-punctureassembly may include a catheter or portion similar to a directionalcatheter to direct/guide a puncturing instrument at the septum, or mayinclude a permanently angled or curved portion to direct/guide thepuncturing instrument at the septum. The septum-puncture assembly mayalso be or include a stabilization assembly to stabilize the assemblyand/or a puncturing instrument in the right ventricle for puncturing theseptum. The septum-puncture assembly or stabilization assembly may bethe same as or similar to septum-puncture/stabilization assembliesdescribed elsewhere herein (e.g., the assemblies shown in 12A-14C). Thisassembly may allow a puncturing instrument to curve, bend, or angletoward the septum and puncture the septum as desired, even when insertedfrom a region remote from the heart. The method may include puncturing aseptum of the heart (e.g., the septum between the right ventricle and aleft ventricle of the heart) with a puncturing instrument.

The method may include identifying a desired puncture location on a wallof the heart (e.g., on a wall of the left ventricle). A device/catheter(e.g., C-shaped device/catheter or a puncture-location device/catheter,which may be the same as or similar to other such devices/catheterdescribed elsewhere herein and/or shown in FIGS. 23A-23C), mayoptionally be used to identify the desired puncture location. Thedevice/catheter may be inserted through an incision on the chest of apatient and navigated around a portion of the heart (e.g., to aposterior wall of the left ventricle). Identification of the desiredpuncture location may be done by moving, pressing, pulling, etc. aportion of the device/catheter against a wall (e.g., an external wall)of the heart while viewing the wall of the heart with imaging equipment(e.g., an echo or ultrasound probe). The moving, pressing, pulling, etc.of the device/catheter may be done so as to cause the wall of the heartto bend or bulge in a manner that is visible on the imaging equipment.The catheter/device may include a movable finger to aid in moving orpressing against the wall of the heart. The method may involvetransitioning the finger from a retracted configuration to an expandedconfiguration to press against the wall. The method may include movingthe device/catheter and/or finger along the wall until a desiredpuncture location is reached. The method may include viewing the wallwith imaging equipment and identifying a desired puncture location whenthe device/catheter and/or finger cause the desired puncture location tobend or bulge. The method may include identifying the desired puncturelocation as a location on the wall away from blood vessels and/orpapillary muscles, e.g., when the bend/bulge appears on the wall in alocation away from the blood vessels and/or papillary muscles.

The method may also include creating an incision or hole (e.g.,puncturing and/or positioning an introducer) in the left and/orposterior wall of the left ventricle from inside the left ventricle tooutside the left ventricle. If the device/catheter above is used toidentify the desired puncture location, puncturing the wall may includedirecting a puncturing instrument and/or introducer at the desiredpuncture location and/or at a bulge/bend in the wall caused by thedevice/catheter above. The device/catheter may include a concave orinwardly tapered surface that can help guide and receive the puncturinginstrument.

The method may also include deploying an anchor near a puncture locationon the wall of the heart (e.g., at the puncture location on the leftventricle wall). If the treatment is remotely done (e.g., access to theheart is from a remote location and through a blood vessel, andincisions are not made to directly access the heart in the region of theincision), then deploying the anchor may involve advancing a deliverycatheter through an access vessel, the right ventricle, the septum, andthe hole/puncture in the wall of the left ventricle. The deliverycatheter may have an anchor (e.g., any of the anchors described hereinor shown in the figures) in a low profile configuration in a lumen ofthe catheter. The method may include deploying a first anchor from thelumen of the delivery catheter and outside the hole such that the firstanchor transitions from the low profile configuration to an expandedconfiguration in a first location outside the heart. The method may alsoinclude pulling a tension member attached to the first anchor such thata portion of a cover of the first anchor is pulled toward the center ofthe expanded configuration (e.g., a circular configuration) to cause thecover to assume a flattened, disc-shape, cone-shape, or othershape/configuration. In one embodiment, the anchor may include amanually expandable ring that can be transitioned from a straightened,low profile configuration to an expanded, ring-like configuration bypulling an actuating wire, member, or cord that pulls the anchor intothe expanded configuration. In one embodiment, the anchor may beexpandable like a balloon by filling a balloon or cover (or portionthereof) with a filling material like beads, spheres, liquid, epoxy,etc.

If the treatment is not done remotely (e.g., it involves open heartsurgery or minimally invasive surgery with local incisions on the chestto access the heart directly, i.e., without first passing through ablood vessel), then the first anchor can still be deployed from adelivery catheter that passes through the right ventricle (possiblyaccessed from outside the wall of the right ventricle or via an accessvessel), the septum, and the hole/puncture in the wall of the leftventricle and then releases the anchor to transition from a low profileconfiguration to an expanded or deployed configuration similar to thedescription above with respect to remote access. The delivery cathetermay be removed after deploying the anchor, thereby leaving the anchorand tension member or cord in place (e.g., the cord/tension member mayremain in the pathway and have an end that extends outside the accesssite).

Optionally, the first anchor could also be deployed directly to the wallof the left ventricle from an incision in the chest. For example, theC-shaped device/catheter could include a lumen through which the tensionmember and anchor pass for deployment. Optionally, a second C-shapeddevice/catheter or other device/catheter could include a lumen throughwhich the tension member and anchor pass for deployment. A snare may bepassed from inside the heart to outside the heart via the hole/puncturein the wall of the left ventricle, and the snare could grab or ensnarethe tension member. The snare could be withdrawn back into the leftventricle and through the septum (and optionally out of a hole in thewall of the right ventricle) while holding the tension member andbringing the tension member with it. The first anchor could be deployedagainst the wall of the left ventricle near the hole/puncture, and thetension member could be attached to a second anchor deployed at theseptum or outside the right ventricle.

Methods may comprise deploying a second anchor in a second location, thesecond location being external to the heart outside the right ventricleor inside the right ventricle against a wall of the septum. The tensionmember may be attached to the first anchor and the second anchor and maybe cinched/tensioned/pulled such that the first anchor and the secondanchor are pulled toward each other and thereby alter the shape of theheart such that leaflets of the mitral valve overlap and better preventmitral valve regurgitation. The tension member may then be securedrelative to the first anchor and the second anchor such that the firstanchor and the second anchor maintain the leaflets of the mitral valvesuch that they overlap. A clamp, auto-knotting device, crimping device,cord locker, or similar device maybe used to lock the tension memberrelative to an anchor (e.g., the second anchor). Any excess cord ortension member may be cut and removed, e.g., using a suture cuttercatheter or other cutting device.

In the methods described herein, the puncturing instrument may be aflexible needle having slits along a length of the flexible needle, andthe step of puncturing the septum may include using the flexible needleto penetrate and pass through the septum. The puncturing instrument maybe a needle, and the step of puncturing the septum may include deployinga spade-shaped assembly in the right ventricle of the heart to stabilizethe needle as the needle penetrates the septum. Optionally, thepuncturing instrument may be an introducer assembly including a needlecatheter having an introducer disposed in a lumen of the needlecatheter, the introducer including an atraumatic distal end, and thestep of puncturing the septum may include pushing the introducerassembly against the septum such that the atraumatic distal end of theintroducer retracts into the needle catheter and a beveled edge of theneedle catheter contacts and punctures the septum, and wherein after theneedle catheter passes through the septum, the atraumatic distal end mayextend from the needle catheter such that the introducer prevents thebeveled edge from causing damage to surrounding tissue. The introducermay be locked in the extended position to prevent damage from thebeveled edge. The method may also comprise passing a guidewire through aguidewire lumen in the introducer and into the left ventricle.

The puncturing instrument may be a trocar catheter including a cannulabeing generally elongate and having an interior lumen; a trocar disposedwithin the interior lumen and extending to a trocar distal tipcomprising one or more surfaces (e.g., grinding plane surfaces)configured to allow the distal tip to puncture heart tissue; and thetrocar catheter further comprising a proximal handle comprising controlsconfigured to facilitate advancing the trocar distal tip beyond a distalend of the cannula during puncturing of heart tissue, the controlsfurther configured to withdraw the trocar distal tip into the distal endof the cannula, and the step of puncturing the septum may includeextending the trocar distal tip from the cannula, puncturing the septum,and withdrawing the trocar distal tip into the cannula to preventfurther puncturing of heart tissue. The trocar may include a centrallumen and one or more lateral ports disposed on the trocar distal tipand in fluid communication with the central lumen of the trocar, thecentral lumen and the one or more lateral ports being configured forcontrast injection; and the step of puncturing the septum may includeinjecting contrast fluid into the heart via the central lumen and theone or more lateral ports, and imaging the trocar catheter andsurrounding heart tissue during puncturing the septum. The step ofcreating a hole in the left and/or posterior wall of the left ventriclefrom inside the left ventricle to outside the left ventricle may includeusing a needle, needle catheter, or trocar to penetrate the left and/orposterior wall.

Methods may also comprise using a threaded introducer comprising anelongate member including a proximal head and a distal end; a centrallumen extending from the proximal head to the distal end, the centrallumen being configured for contrast injection; at least one lateral portdisposed on the distal end in fluid communication with the centrallumen; and threading disposed along a length of the threaded introducer;and the step of creating a hole in the posterior wall of the leftventricle from inside the left ventricle to outside the left ventriclemay include rotating the threaded introducer against the posterior wallsuch that the threading rotatably engages with the posterior wallthereby advances the threaded introducer into the posterior wall in acontrolled manner.

The first anchor may comprise a ring and a cover, the ring havingatraumatic ends which meet at a break, the ring being in a straightenedconfiguration in the lumen of a delivery catheter, and when deployingthe first anchor from the lumen of the delivery catheter and outside thehole the ring may transition automatically to a ring-shapedconfiguration thereby causing the first anchor to transition from thelow profile configuration to the expanded configuration.

Methods may further comprise suturing a portion of the heart with asuture and using a suture cutter catheter to cut a portion of thesuture, wherein the suture cutter catheter comprises an inflatableballoon, a moving plate, and wherein inflation of the balloon causes themoving plate to press the suture into the blade to cut the suture. Thesuture cutter catheter may be used to cut suture and/or the tensionmember or excess thereof after cinching and locking the anchorstogether.

Methods of manufacture of the various systems, apparatuses, devices,etc. described herein may include creating the different components ofthe various systems, apparatuses, devices, etc., e.g., by mold,injection mold, 3D printing, extrusion, machining, grinding, milling,laser, and/or other methods. Methods of manufacture of the varioussystems, apparatuses, devices, etc. may also include assembling and/orattaching the components of the of the various systems, apparatuses,devices, etc. described herein in the arrangements/configurationsdescribed herein and/or shown in the figures. Attachments betweencomponents may be done by adhering, tying, bonding, fastening, frictionfit, and/or otherwise securing the components together.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. To the extent there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it isthe intent that this patent will cover those variations as well.Therefore, the present disclosure is to be understood as not limited bythe specific embodiments described herein, but only by scope of theappended claims.

What is claimed is:
 1. An anchoring system for treatment of a dilatedheart condition or functional heart valve regurgitation comprising: ananchor for setting a valve splint, the anchor having a low-profileconfiguration such that the anchor can fit within a lumen of a deliverycatheter for transcatheter delivery of the anchor and an expandedconfiguration for anchoring the valve splint; a needle capable ofpenetrating a wall of a heart; and a spade-shaped assembly configured tobe deployed in a chamber of the heart such that the spade shapedassembly contacts opposite sides of the chamber of the heart andstabilizes the needle when the needle is used to penetrate the wall ofthe heart.
 2. The anchoring system of claim 1, wherein the anchorcomprises a wire that, in the expanded configuration, is coiled and hasa base portion and a top portion, the base portion being configured tocontact an exterior surface of the heart, the top portion being directlyor indirectly connected to a tension member such that the tension membercan be drawn through the center of the coiled wire and a puncture in theheart, and wherein the base portion has a larger diameter than the topportion.
 3. The anchoring system of claim 1, wherein the anchorcomprises a wire having atraumatic ends that meet at a break, whereinthe wire assumes an elongate, linear configuration when in thelow-profile configuration and assumes a ring-shaped configuration whenin the expanded configuration.
 4. The anchoring system of claim 3,wherein the wire is configured to transition automatically from theelongate, linear configuration to the ring-shaped configuration uponbeing pushed out of the lumen of the delivery catheter.
 5. The anchoringsystem of claim 4, wherein the anchor further comprises a coversupported by the wire, and wherein the cover is engaged with a tensionmember such that pulling the tension member tightens the cover into acircular or a cone-like configuration.
 6. The anchoring system of claim1, wherein the anchor further comprises a cover, the cover having asurface area suitable to prevent migration of the anchor into the heartand to withstand forces due to tension of the tension member of at least17 Newtons (N).
 7. The anchoring system of claim 1, wherein thespade-shaped assembly comprises a wire spade connected to a catheter byway of a catheter head, and an orientation handle located at a proximalend of the catheter configured to provide control of an angle between atip of the needle and the catheter.
 8. The anchoring system of claim 1,wherein the chamber of the heart is a right ventricle of the heart andthe wall of the heart is a septum between the right ventricle and a leftventricle of the heart.
 9. The anchoring system of claim 8, wherein aninner needle is disposed within an inner lumen of the needle, the innerneedle is configured to be advanced from the needle across the leftventricle and to puncture a posterior wall of the left ventricle. 10.The anchoring system of claim 1, further comprising a cutter catheterincluding a blade and an inflatable balloon within the catheter, thecutter catheter configured such that the balloon may be inflated fromoutside a patient's body to cause the blade to cut a suture or tensionmember at a location inside the patient's body.
 11. A method fortreating heart dilation or heart valve regurgitation, the methodcomprising: inserting a puncturing instrument having a sharp distal tipinto a right ventricle of a heart; puncturing a septum of the heartbetween the right ventricle and a left ventricle of the heart with thepuncturing instrument; creating a hole in the posterior wall of the leftventricle from inside the left ventricle to outside the left ventricle;advancing a delivery catheter having a first anchor in a low profileconfiguration through the septum and to the hole in the posterior wall;and deploying the first anchor outside the hole using the deliverycatheter and transitioning the first anchor from the low profileconfiguration to an expanded configuration in a first location outsidethe heart.
 12. The method of claim 11, wherein the anchor includes aballoon, and wherein transitioning the first anchor from a low profileconfiguration to an expanded configuration further comprises filling theballoon with a filler material selected from the group consisting of anepoxy, spheres, and a coil.
 13. The method of claim 11, wherein theanchor includes a wire that forms a ring-like shape in the expandedconfiguration, and wherein transitioning the first anchor from a lowprofile configuration to an expanded configuration further comprisespulling a tension member attached to the first anchor such that aportion of a cover of the first anchor is pulled closer to a center ofthe ring-like shape.
 14. The method of claim 12, wherein the wire isself-expandable and can automatically transition to the ring-like shape,and wherein transitioning the first anchor from a low profileconfiguration to an expanded configuration comprises pushing the wireout from the delivery catheter such that the wire transitionsautomatically to the ring-like shape as it exits the delivery catheter.15. The method of claim 11, further comprising deploying a second anchorin a second location, the second location being outside the rightventricle against an outer wall of the heart or inside the rightventricle against a wall of the septum.
 16. The method of claim 15,further comprising cinching the tension member such that the firstanchor and the second anchor are pulled toward each other and therebyalter the shape of the heart such that leaflets of the mitral valveoverlap and better prevent mitral valve regurgitation.
 17. The method ofclaim 11, wherein the puncturing instrument is a needle, and whereinpuncturing the septum includes deploying a spade-shaped assembly in theright ventricle of the heart to stabilize the needle as the needlepenetrates the septum.
 18. A heart anchor for securing a mitral valvesplint, the heart anchor comprising: a ring having atraumatic ends whichmeet at a break, the ring capable of being straightened from aring-shaped configuration to a linear configuration and loaded into alumen of a delivery catheter, wherein the ring comprises a shape memorymaterial and is configured to transition automatically to thering-shaped configuration when deployed from the delivery catheter; anda cover supported by the ring.
 19. The heart anchor of claim 18, whereinthe cover is engaged with a tension member such that pulling the tensionmember can tighten the cover.
 20. The heart anchor of claim 18, whereinthe cover comprises a surface area suitable to withstand forces due totension of at least 17 Newtons (N) when pulled against a heart by atension member.